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1.
Am J Trop Med Hyg ; 106(1): 342-344, 2021 10 25.
Artículo en Inglés | MEDLINE | ID: covidwho-2232250

RESUMEN

Although rare in Portugal, snakebite envenoming entails severe morbidity and mortality. We present the case of a 65-year-old woman bitten on her leg in a northern coastal region in Portugal, on a walk during the COVID-19 pandemic lockdown. Despite first looking for help at the nearest pharmacy, she developed anaphylactoid shock and was promptly driven to a tertiary hospital, where antivenom was administered in a timely manner under close monitoring. Prophylactic antibiotics were started and maintained based on elevated inflammatory markers and signs of wound inflammation. She evolved favorably, with rapid weaning of vasopressors and resolution of end-organ dysfunction. This case highlights the importance of prompt recognition and describes crucial steps in envenomation management in a country where snakebite is infrequent, but potentially fatal.


Asunto(s)
Anafilaxia/epidemiología , Anafilaxia/etiología , Mordeduras de Serpientes/complicaciones , Mordeduras de Serpientes/epidemiología , Anciano , Anafilaxia/terapia , Antibacterianos/administración & dosificación , Antivenenos/administración & dosificación , Ceftriaxona/administración & dosificación , Clindamicina/administración & dosificación , Femenino , Humanos , Portugal/epidemiología , Mordeduras de Serpientes/terapia , Toxoide Tetánico/administración & dosificación , Resultado del Tratamiento
2.
Cornea ; 40(11): 1502-1504, 2021 Nov 01.
Artículo en Inglés | MEDLINE | ID: covidwho-2063050
3.
N Engl J Med ; 386(14): 1327-1338, 2022 04 07.
Artículo en Inglés | MEDLINE | ID: covidwho-1778677

RESUMEN

BACKGROUND: There is a need for oral antibiotic agents that are effective against multidrug-resistant gram-negative uropathogens. Tebipenem pivoxil hydrobromide is an orally bioavailable carbapenem with activity against uropathogenic Enterobacterales, including extended-spectrum beta-lactamase-producing and fluoroquinolone-resistant strains. METHODS: In this phase 3, international, double-blind, double-dummy trial, we evaluated the efficacy and safety of orally administered tebipenem pivoxil hydrobromide as compared with intravenous ertapenem in patients with complicated urinary tract infection or acute pyelonephritis. Patients were randomly assigned, in a 1:1 ratio, to receive oral tebipenem pivoxil hydrobromide (at a dose of 600 mg every 8 hours) or intravenous ertapenem (at a dose of 1 g every 24 hours) for 7 to 10 days (or up to 14 days in patients with bacteremia). The primary efficacy end point was overall response (a composite of clinical cure and favorable microbiologic response) at a test-of-cure visit (on day 19, within a ±2-day window) in the microbiologic intention-to-treat population. The noninferiority margin was 12.5%. RESULTS: A total of 1372 hospitalized adult patients were enrolled; 868 patients (63.3%) were included in the microbiologic intention-to-treat population (50.8% of whom had complicated urinary tract infections and 49.2% of whom had pyelonephritis). An overall response was seen in 264 of 449 patients (58.8%) who received tebipenem pivoxil hydrobromide, as compared with 258 of 419 patients (61.6%) who received ertapenem (weighted difference, -3.3 percentage points; 95% confidence interval [CI], -9.7 to 3.2). Clinical cure at the test-of-cure visit was observed in 93.1% of the patients in the microbiologic intention-to-treat population who received tebipenem pivoxil hydrobromide and 93.6% of patients who received ertapenem (weighted difference, -0.6 percentage point; 95% CI, -4.0 to 2.8); the majority of patients with microbiologic response failures at the test-of-cure visit were asymptomatic patients with recurrent bacteriuria. Secondary and subgroup analyses were supportive of the primary analysis. Adverse events were observed in 25.7% of patients who received tebipenem pivoxil hydrobromide and in 25.6% of patients who received ertapenem; the most common adverse events were mild diarrhea and headache. CONCLUSIONS: Oral tebipenem pivoxil hydrobromide was noninferior to intravenous ertapenem in the treatment of complicated urinary tract infection and acute pyelonephritis and had a similar safety profile. (Funded by Spero Therapeutics and the Department of Health and Human Services; ADAPT-PO ClinicalTrials.gov number, NCT03788967.).


Asunto(s)
Antibacterianos , Carbapenémicos , Pielonefritis , Infecciones Urinarias , Administración Intravenosa , Administración Oral , Adulto , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Antibacterianos/uso terapéutico , Carbapenémicos/administración & dosificación , Carbapenémicos/efectos adversos , Carbapenémicos/uso terapéutico , Método Doble Ciego , Farmacorresistencia Bacteriana Múltiple , Ertapenem/administración & dosificación , Ertapenem/efectos adversos , Ertapenem/uso terapéutico , Humanos , Pielonefritis/tratamiento farmacológico , Infecciones Urinarias/tratamiento farmacológico , Infecciones Urinarias/microbiología
5.
Am J Trop Med Hyg ; 105(6): 1472-1475, 2021 Oct 04.
Artículo en Inglés | MEDLINE | ID: covidwho-1629955

RESUMEN

Human lives and nations' economies have been adversely affected worldwide by the COVID-19 pandemic. The hyperinflammatory state associated with the disease may be related to mortality. Systemic glucocorticoid is the first-line therapy for cytokine storm. Various immunomodulatory drugs such as tocilizumab and baricitinib have been used in those not responding to glucocorticoid monotherapy. Amid the peak crisis of COVID-19 in India, there was an extreme paucity of medications, oxygen, and hospital beds. We describe three patients with COVID-19 who received low-dose tofacitinib (an oral Janus kinase inhibitor) in addition to moderate-dose glucocorticoid. These patients were treated at their homes, as the hospitals were short of beds. Rapid reduction in hypoxemia along with gradual resolution of other signs of the disease were observed. The results are reassuring regarding the feasibility of managing of severe COVID-19 outside the hospital setting when healthcare resources are overwhelmed by pandemic-related caseload.


Asunto(s)
Tratamiento Farmacológico de COVID-19 , Piperidinas/uso terapéutico , Pirimidinas/uso terapéutico , SARS-CoV-2 , Adulto , Anciano , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Antiinflamatorios/uso terapéutico , Síndrome de Liberación de Citoquinas/prevención & control , Citocinas/genética , Citocinas/metabolismo , Enoxaparina/administración & dosificación , Enoxaparina/uso terapéutico , Femenino , Regulación de la Expresión Génica/efectos de los fármacos , Humanos , Metilprednisolona/administración & dosificación , Metilprednisolona/uso terapéutico , Persona de Mediana Edad , Piperidinas/administración & dosificación , Prednisona/administración & dosificación , Prednisona/uso terapéutico , Pirimidinas/administración & dosificación
6.
N Engl J Med ; 386(3): 230-240, 2022 01 20.
Artículo en Inglés | MEDLINE | ID: covidwho-1630266

RESUMEN

BACKGROUND: Rheumatic heart disease affects more than 40.5 million people worldwide and results in 306,000 deaths annually. Echocardiographic screening detects rheumatic heart disease at an early, latent stage. Whether secondary antibiotic prophylaxis is effective in preventing progression of latent rheumatic heart disease is unknown. METHODS: We conducted a randomized, controlled trial of secondary antibiotic prophylaxis in Ugandan children and adolescents 5 to 17 years of age with latent rheumatic heart disease. Participants were randomly assigned to receive either injections of penicillin G benzathine (also known as benzathine benzylpenicillin) every 4 weeks for 2 years or no prophylaxis. All the participants underwent echocardiography at baseline and at 2 years after randomization. Changes from baseline were adjudicated by a panel whose members were unaware of the trial-group assignments. The primary outcome was echocardiographic progression of latent rheumatic heart disease at 2 years. RESULTS: Among 102,200 children and adolescents who had screening echocardiograms, 3327 were initially assessed as having latent rheumatic heart disease, and 926 of the 3327 subsequently received a definitive diagnosis on the basis of confirmatory echocardiography and were determined to be eligible for the trial. Consent or assent for participation was provided for 916 persons, and all underwent randomization; 818 participants were included in the modified intention-to-treat analysis, and 799 (97.7%) completed the trial. A total of 3 participants (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, as compared with 33 (8.2%) in the control group (risk difference, -7.5 percentage points; 95% confidence interval, -10.2 to -4.7; P<0.001). Two participants in the prophylaxis group had serious adverse events that were attributable to receipt of prophylaxis, including one episode of a mild anaphylactic reaction (representing <0.1% of all administered doses of prophylaxis). CONCLUSIONS: Among children and adolescents 5 to 17 years of age with latent rheumatic heart disease, secondary antibiotic prophylaxis reduced the risk of disease progression at 2 years. Further research is needed before the implementation of population-level screening can be recommended. (Funded by the Thrasher Research Fund and others; GOAL ClinicalTrials.gov number, NCT03346525.).


Asunto(s)
Antibacterianos/uso terapéutico , Profilaxis Antibiótica , Penicilina G Benzatina/uso terapéutico , Cardiopatía Reumática/tratamiento farmacológico , Adolescente , Antibacterianos/administración & dosificación , Niño , Preescolar , Progresión de la Enfermedad , Ecocardiografía , Femenino , Humanos , Inyecciones Intramusculares , Análisis de Intención de Tratar , Infección Latente/tratamiento farmacológico , Masculino , Tamizaje Masivo , Penicilina G Benzatina/administración & dosificación , Cardiopatía Reumática/diagnóstico por imagen , Uganda
7.
Pan Afr Med J ; 38: 74, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1547719

RESUMEN

Boerhaave's syndrome is an uncommon syndrome characterized by spontaneous rupture of the oesophagus with a high mortality rate. While excessive alcohol intake and binge-eating are the classic precipitants of this syndrome, medication-induced vomiting causing Booerhave's is quite uncommon. Traditionally managed operatively, conservative management is being increasingly reported in selected cases. We report the case of 21-year-old male with who developed sudden onset chest pain and dyspnoea after pentazocine induced vomiting. He was referred after lack of response to initial treatment for acute severe asthma. A chest CT scan showed pneumomediastinum, subcutaneous emphysema and oesophageal tear. He was managed conservatively with oxygen therapy, nil per mouth and antibiotics with improvement of symptoms and discharge after 8 days.


Asunto(s)
Perforación del Esófago/diagnóstico por imagen , Enfermedades del Mediastino/diagnóstico por imagen , Pentazocina/efectos adversos , Vómitos/complicaciones , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Antibacterianos/administración & dosificación , Asma/fisiopatología , Asma/terapia , Dolor en el Pecho/etiología , Disnea/etiología , Perforación del Esófago/etiología , Perforación del Esófago/terapia , Humanos , Masculino , Enfermedades del Mediastino/etiología , Enfermedades del Mediastino/terapia , Terapia por Inhalación de Oxígeno , Pentazocina/administración & dosificación , Tomografía Computarizada por Rayos X , Vómitos/inducido químicamente , Adulto Joven
8.
Lancet Infect Dis ; 21(5): 657-667, 2021 05.
Artículo en Inglés | MEDLINE | ID: covidwho-1510463

RESUMEN

BACKGROUND: Bacterial sexually transmitted infections (STIs) are highly prevalent among men who have sex with men who use HIV pre-exposure prophylaxis (PrEP), which leads to antimicrobial consumption linked to the emergence of antimicrobial resistance. We aimed to assess use of an antiseptic mouthwash as an antibiotic sparing approach to prevent STIs. METHODS: We invited people using PrEP who had an STI in the past 24 months to participate in this single-centre, randomised, double-blind, placebo-controlled, AB/BA crossover superiority trial at the Institute of Tropical Medicine in Antwerp, Belgium. Using block randomisation (block size eight), participants were assigned (1:1) to first receive Listerine Cool Mint or a placebo mouthwash. They were required to use the study mouthwashes daily and before and after sex for 3 months each and to ask their sexual partners to use the mouthwash before and after sex. Participants were screened every 3 months for syphilis, chlamydia, and gonorrhoea at the oropharynx, anorectum, and urethra. The primary outcome was combined incidence of these STIs during each 3-month period, assessed in the intention-to-treat population, which included all participants who completed at least the first 3-month period. Safety was assessed as a secondary outcome. This trial is registered with Clinicaltrials.gov, NCT03881007. FINDINGS: Between April 2, 2019, and March 13, 2020, 343 participants were enrolled: 172 in the Listerine followed by placebo (Listerine-placebo) group and 171 in the placebo followed by Listerine (placebo-Listerine) group. The trial was terminated prematurely because of the COVID-19 pandemic. 151 participants completed the entire study, and 89 completed only the first 3-month period. 31 participants withdrew consent, ten were lost to follow-up, and one acquired HIV. In the Listerine-placebo group, the STI incidence rate was 140·4 per 100 person-years during the Listerine period, and 102·6 per 100 person-years during the placebo period. In the placebo-Listerine arm, the STI incidence rate was 133·9 per 100 person-years during the placebo period, and 147·5 per 100 person-years during the Listerine period. We did not find that Listerine significantly reduced STI incidence (IRR 1·17, 95% CI 0·84-1·64). Numbers of adverse events were not significantly higher than at baseline and were similar while using Listerine and placebo. Four serious adverse events (one HIV-infection, one severe depression, one Ludwig's angina, and one testicular carcinoma) were not considered to be related to use of mouthwash. INTERPRETATION: Our findings do not support the use of Listerine Cool Mint as a way to prevent STI acquisition among high-risk populations. FUNDING: Belgian Research Foundation - Flanders (FWO 121·00).


Asunto(s)
Antibacterianos/administración & dosificación , Infecciones por VIH/prevención & control , Homosexualidad Masculina , Antisépticos Bucales , Profilaxis Pre-Exposición , Enfermedades de Transmisión Sexual/prevención & control , Adulto , Estudios Cruzados , Método Doble Ciego , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Enfermedades de Transmisión Sexual/epidemiología
9.
Ther Drug Monit ; 43(4): 451-454, 2021 08 01.
Artículo en Inglés | MEDLINE | ID: covidwho-1501177

RESUMEN

OBJECTIVE: The authors report on a case of a 59-year-old man hospitalized in the intensive care unit because of severe SARS-COV-2 infection (COVID-19). BACKGROUND: The patient had several comorbidities, including liver cirrhosis. He developed ventilation-associated bacterial pneumonia for which he was administered cefepime at an initial dose of 2 g/8 hours. Therapeutic drug monitoring was performed, showing overexposure with an initial trough concentration of >60 mg/L. METHODS: Analysis of pharmacokinetic data and model-based dose adjustment was performed using BestDose software. RESULTS: The patient had unexpected pharmacokinetic parameter values. Serum creatinine was only moderately increased, whereas measured creatinine clearance based on urine collection showed impaired renal function. Bacterial minimum inhibitory concentration was also considered in the dosing decisions. After dose reduction to 0.5 g/8 hours, the cefepime trough concentration progressively declined and reached the target values by the end of the therapy. A post-hoc analysis provided a different interpretation of drug overexposure. CONCLUSION: This case report illustrates how physiological, microbiological, and drug concentration data can be used for model-based dosage individualization of cefepime in intensive care unit patients.


Asunto(s)
Antibacterianos/farmacocinética , Cefepima/farmacocinética , Enfermedad Crítica/terapia , Cálculo de Dosificación de Drogas , Medicina de Precisión/métodos , Lesión Renal Aguda/sangre , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/prevención & control , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Cefepima/administración & dosificación , Cefepima/efectos adversos , Humanos , Masculino , Persona de Mediana Edad
10.
Am J Trop Med Hyg ; 105(6): 1519-1520, 2021 10 29.
Artículo en Inglés | MEDLINE | ID: covidwho-1497591

RESUMEN

In this study, we described the proportion of COVID-19 patients started on antibiotics empirically and the work-ups performed to diagnose bacterial superinfection. We used a retrospective cohort study design involving medical records of symptomatic, hospitalized COVID-19 patients who were admitted to these centers. A total of 481 patients were included, with a median age of 41.0 years (interquartile range, 28-58.5 years). A total of 72.1% (N = 347) of COVID-19 patients received antibiotics, either before or during admission. This is troublesome because none of the patients' bacterial culture or inflammatory markers, such as the erythrocyte sedimentation rate or C-reactive protein, were evaluated, and only 73 (15.2%) underwent radiological investigations. Therefore, national COVID-19 guidelines should emphasize the rational use of antibiotics for the treatment of COVID-19, a primarily viral disease. Integrating antimicrobial stewardship into the COVID-19 response and expanding microbiological capacities in low-income countries are indispensable. Otherwise, we risk one pandemic aggravating another.


Asunto(s)
Antibacterianos/administración & dosificación , Tratamiento Farmacológico de COVID-19 , SARS-CoV-2 , Adulto , Programas de Optimización del Uso de los Antimicrobianos , Infecciones Bacterianas/diagnóstico , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/epidemiología , Estudios de Cohortes , Etiopía/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Estudios Retrospectivos , Sobreinfección/diagnóstico , Sobreinfección/tratamiento farmacológico
11.
Ann Med ; 53(1): 1863-1874, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: covidwho-1483235

RESUMEN

OBJECTIVE: To compare the performance of the Risk-stratification of Emergency Department suspected Sepsis (REDS) score to the SIRS criteria, NEWS2, CURB65, SOFA, MEDS and PIRO scores, to risk-stratify Emergency Department (ED) suspected sepsis patients for mortality. METHOD: A retrospective observational cohort study of prospectively collected data. Adult patients admitted from the ED after receiving intravenous antibiotics for suspected sepsis in the year 2020, were studied. Patients with COVID-19 were excluded. The scores stated above were calculated for each patient. Receiver operator characteristics (ROC) curves were constructed for each score for the primary outcome measure, all-cause in-hospital mortality. The area under the ROC (AUROC) curves and cut-off points were identified by the statistical software. Scores above the cut-off point were deemed high-risk. The test characteristics of the high-risk groups were calculated. Comparisons were based on the AUROC curve and sensitivity for mortality of the high-risk groups. Previously published cut-off points were also studied. Calibration was also studied. RESULTS: Of the 2594 patients studied, 332 (12.8%) died. The AUROC curve for the REDS score 0.73 (95% confidence interval [CI] 0.72-0.75) was significantly greater than the AUROC curve for the SIRS criteria 0.51 (95% CI 0.49-0.53), p < .0001 and the NEWS2 score 0.69 (95% CI 0.67-0.70), p = .005, and similar to all other scores studied. Sensitivity for mortality at the respective cut-off points identified (REDS ≥3, NEWS2 ≥ 8, CURB65 ≥ 3, SOFA ≥3, MEDS ≥10 and PIRO ≥10) was greatest for the REDS score at 80.1% (95% CI 75.4-84.3) and significantly greater than the other scores. The sensitivity for mortality for an increase of two points from baseline in the SOFA score was 63% (95% CI 57.5-68.2). CONCLUSIONS: In this single centre study, the REDS score had either a greater AUROC curve or sensitivity for mortality compared to the comparator scores, at the respective cut-off points identified.KEY MESSAGESThe REDS score is a simple and objective scoring system to risk-stratify for mortality in emergency department (MED) patients with suspected sepsis.The REDS score is better or equivalent to existing scoring systems in its discrimination for mortality.


Asunto(s)
Antibacterianos/administración & dosificación , Servicio de Urgencia en Hospital/estadística & datos numéricos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Sepsis/mortalidad , Índice de Severidad de la Enfermedad , Administración Intravenosa , Anciano , Anciano de 80 o más Años , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Curva ROC , Estudios Retrospectivos , Medición de Riesgo/métodos , Sepsis/diagnóstico , Sepsis/tratamiento farmacológico
12.
Lancet ; 398(10309): 1417-1426, 2021 10 16.
Artículo en Inglés | MEDLINE | ID: covidwho-1432164

RESUMEN

BACKGROUND: Antibiotic resistance is a global public health threat. Antibiotics are very commonly prescribed for children presenting with uncomplicated lower respiratory tract infections (LRTIs), but there is little evidence from randomised controlled trials of the effectiveness of antibiotics, both overall or among key clinical subgroups. In ARTIC PC, we assessed whether amoxicillin reduces the duration of moderately bad symptoms in children presenting with uncomplicated (non-pneumonic) LRTI in primary care, overall and in key clinical subgroups. METHODS: ARTIC PC was a double-blind, randomised, placebo-controlled trial done at 56 general practices in England. Eligible children were those aged 6 months to 12 years presenting in primary care with acute uncomplicated LRTI judged to be infective in origin, where pneumonia was not suspected clinically, with symptoms for less than 21 days. Patients were randomly assigned in a 1:1 ratio to receive amoxicillin 50 mg/kg per day or placebo oral suspension, in three divided doses orally for 7 days. Patients and investigators were masked to treatment assignment. The primary outcome was the duration of symptoms rated moderately bad or worse (measured using a validated diary) for up to 28 days or until symptoms resolved. The primary outcome and safety were assessed in the intention-to-treat population. The trial is registered with the ISRCTN Registry (ISRCTN79914298). FINDINGS: Between Nov 9, 2016, and March 17, 2020, 432 children (not including six who withdrew permission for use of their data after randomisation) were randomly assigned to the antibiotics group (n=221) or the placebo group (n=211). Complete data for symptom duration were available for 317 (73%) patients; missing data were imputed for the primary analysis. Median durations of moderately bad or worse symptoms were similar between the groups (5 days [IQR 4-11] in the antibiotics group vs 6 days [4-15] in the placebo group; hazard ratio [HR] 1·13 [95% CI 0·90-1·42]). No differences were seen for the primary outcome between the treatment groups in the five prespecified clinical subgroups (patients with chest signs, fever, physician rating of unwell, sputum or chest rattle, and short of breath). Estimates from complete-case analysis and a per-protocol analysis were similar to the imputed data analysis. INTERPRETATION: Amoxicillin for uncomplicated chest infections in children is unlikely to be clinically effective either overall or for key subgroups in whom antibiotics are commonly prescribed. Unless pneumonia is suspected, clinicians should provide safety-netting advice but not prescribe antibiotics for most children presenting with chest infections. FUNDING: National Institute for Health Research.


Asunto(s)
Amoxicilina/uso terapéutico , Antibacterianos/uso terapéutico , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Administración Oral , Amoxicilina/administración & dosificación , Antibacterianos/administración & dosificación , Niño , Preescolar , Método Doble Ciego , Inglaterra , Femenino , Humanos , Lactante , Masculino , Atención Primaria de Salud , Resultado del Tratamiento
13.
J Laryngol Otol ; 135(10): 855-857, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: covidwho-1434031

RESUMEN

OBJECTIVE: Recurrent acute otitis media is common in children. The preferred treatment measures for recurrent acute otitis media have a mixed evidence base. This study sought to assess baseline practice across ENT departments in England. METHODS: A national telephone survey of healthcare staff was conducted. Every ENT centre in England was contacted. A telephone script was used to ask about antibiotic and grommet use and duration in recurrent acute otitis media cases. RESULTS: Ninety-six centres (74 per cent) provided complete information. Recurrent acute otitis media treatment across England by ENT departments varied. The antibiotic first- and second-line prophylaxis offered varies, with trimethoprim used in 33 centres and 29 centres not offering any antibiotics. The timing or choice about when to use grommets also varies, but 87 centres (91 per cent) offer grommet surgery at one stage. CONCLUSION: The treatments received by children in England for recurrent acute otitis media vary by centre; collaborative research in this area is advised.


Asunto(s)
Ventilación del Oído Medio/estadística & datos numéricos , Otitis Media/tratamiento farmacológico , Otolaringología/estadística & datos numéricos , Encuestas y Cuestionarios/normas , Enfermedad Aguda , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Antiinfecciosos Urinarios/administración & dosificación , Antiinfecciosos Urinarios/uso terapéutico , Niño , Farmacorresistencia Microbiana , Inglaterra/epidemiología , Humanos , Ventilación del Oído Medio/métodos , Otitis Media/cirugía , Otolaringología/organización & administración , Atención Individual de Salud/estadística & datos numéricos , Recurrencia , Medicina Estatal/organización & administración , Encuestas y Cuestionarios/estadística & datos numéricos , Trimetoprim/administración & dosificación , Trimetoprim/uso terapéutico
15.
Br J Haematol ; 190(1): e1-e3, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: covidwho-1388215
17.
JAMA ; 326(6): 490-498, 2021 08 10.
Artículo en Inglés | MEDLINE | ID: covidwho-1363618

RESUMEN

Importance: Azithromycin has been hypothesized to have activity against SARS-CoV-2. Objective: To determine whether oral azithromycin in outpatients with SARS-CoV-2 infection leads to absence of self-reported COVID-19 symptoms at day 14. Design, Setting, and Participants: Randomized clinical trial of azithromycin vs matching placebo conducted from May 2020 through March 2021. Outpatients from the US were enrolled remotely via internet-based surveys and followed up for 21 days. Eligible participants had a positive SARS-CoV-2 diagnostic test result (nucleic acid amplification or antigen) within 7 days prior to enrollment, were aged 18 years or older, and were not hospitalized at the time of enrollment. Among 604 individuals screened, 297 were ineligible, 44 refused participation, and 263 were enrolled. Participants, investigators, and study staff were masked to treatment randomization. Interventions: Participants were randomized in a 2:1 fashion to a single oral 1.2-g dose of azithromycin (n = 171) or matching placebo (n = 92). Main Outcomes and Measures: The primary outcome was absence of self-reported COVID-19 symptoms at day 14. There were 23 secondary clinical end points, including all-cause hospitalization at day 21. Results: Among 263 participants who were randomized (median age, 43 years; 174 [66%] women; 57% non-Hispanic White and 29% Latinx/Hispanic), 76% completed the trial. The trial was terminated by the data and safety monitoring committee for futility after the interim analysis. At day 14, there was no significant difference in proportion of participants who were symptom free (azithromycin: 50%; placebo: 50%; prevalence difference, 0%; 95% CI, -14% to 15%; P > .99). Of 23 prespecified secondary clinical end points, 18 showed no significant difference. By day 21, 5 participants in the azithromycin group had been hospitalized compared with 0 in the placebo group (prevalence difference, 4%; 95% CI, -1% to 9%; P = .16). Conclusions and Relevance: Among outpatients with SARS-CoV-2 infection, treatment with a single dose of azithromycin compared with placebo did not result in greater likelihood of being symptom free at day 14. These findings do not support the routine use of azithromycin for outpatient SARS-CoV-2 infection. Trial Registration: ClinicalTrials.gov Identifier: NCT04332107.


Asunto(s)
Antibacterianos/uso terapéutico , Azitromicina/uso terapéutico , Tratamiento Farmacológico de COVID-19 , SARS-CoV-2 , Administración Oral , Adulto , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Azitromicina/administración & dosificación , Azitromicina/efectos adversos , COVID-19/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pacientes Ambulatorios , Evaluación de Síntomas , Insuficiencia del Tratamiento
18.
Lancet Respir Med ; 9(9): 1010-1020, 2021 09.
Artículo en Inglés | MEDLINE | ID: covidwho-1331331

RESUMEN

BACKGROUND: Doxycycline is often used for treating COVID-19 respiratory symptoms in the community despite an absence of evidence from clinical trials to support its use. We aimed to assess the efficacy of doxycycline to treat suspected COVID-19 in the community among people at high risk of adverse outcomes. METHODS: We did a national, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in older people (PRINCIPLE) across primary care centres in the UK. We included people aged 65 years or older, or 50 years or older with comorbidities (weakened immune system, heart disease, hypertension, asthma or lung disease, diabetes, mild hepatic impairment, stroke or neurological problem, and self-reported obesity or body-mass index of 35 kg/m2 or greater), who had been unwell (for ≤14 days) with suspected COVID-19 or a positive PCR test for SARS-CoV-2 infection in the community. Participants were randomly assigned using response adaptive randomisation to usual care only, usual care plus oral doxycycline (200 mg on day 1, then 100 mg once daily for the following 6 days), or usual care plus other interventions. The interventions reported in this manuscript are usual care plus doxycycline and usual care only; evaluations of other interventions in this platform trial are ongoing. The coprimary endpoints were time to first self-reported recovery, and hospitalisation or death related to COVID-19, both measured over 28 days from randomisation and analysed by intention to treat. This trial is ongoing and is registered with ISRCTN, 86534580. FINDINGS: The trial opened on April 2, 2020. Randomisation to doxycycline began on July 24, 2020, and was stopped on Dec 14, 2020, because the prespecified futility criterion was met; 2689 participants were enrolled and randomised between these dates. Of these, 2508 (93·3%) participants contributed follow-up data and were included in the primary analysis: 780 (31·1%) in the usual care plus doxycycline group, 948 in the usual care only group (37·8%), and 780 (31·1%) in the usual care plus other interventions group. Among the 1792 participants randomly assigned to the usual care plus doxycycline and usual care only groups, the mean age was 61·1 years (SD 7·9); 999 (55·7%) participants were female and 790 (44·1%) were male. In the primary analysis model, there was little evidence of difference in median time to first self-reported recovery between the usual care plus doxycycline group and the usual care only group (9·6 [95% Bayesian Credible Interval [BCI] 8·3 to 11·0] days vs 10·1 [8·7 to 11·7] days, hazard ratio 1·04 [95% BCI 0·93 to 1·17]). The estimated benefit in median time to first self-reported recovery was 0·5 days [95% BCI -0·99 to 2·04] and the probability of a clinically meaningful benefit (defined as ≥1·5 days) was 0·10. Hospitalisation or death related to COVID-19 occurred in 41 (crude percentage 5·3%) participants in the usual care plus doxycycline group and 43 (4·5%) in the usual care only group (estimated absolute percentage difference -0·5% [95% BCI -2·6 to 1·4]); there were five deaths (0·6%) in the usual care plus doxycycline group and two (0·2%) in the usual care only group. INTERPRETATION: In patients with suspected COVID-19 in the community in the UK, who were at high risk of adverse outcomes, treatment with doxycycline was not associated with clinically meaningful reductions in time to recovery or hospital admissions or deaths related to COVID-19, and should not be used as a routine treatment for COVID-19. FUNDING: UK Research and Innovation, Department of Health and Social Care, National Institute for Health Research.


Asunto(s)
Antibacterianos/administración & dosificación , Tratamiento Farmacológico de COVID-19 , Doxiciclina/administración & dosificación , Factores de Edad , Anciano , Anciano de 80 o más Años , Antibacterianos/efectos adversos , COVID-19/diagnóstico , COVID-19/mortalidad , COVID-19/virología , Doxiciclina/efectos adversos , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Diferencia Mínima Clínicamente Importante , Factores de Riesgo , SARS-CoV-2/aislamiento & purificación , Autoinforme/estadística & datos numéricos , Resultado del Tratamiento , Reino Unido/epidemiología
20.
Am J Health Syst Pharm ; 77(17): 1409-1416, 2020 08 20.
Artículo en Inglés | MEDLINE | ID: covidwho-1317900

RESUMEN

PURPOSE: The global coronavirus disease 2019 (COVID-19) pandemic has created unprecedented strains on healthcare systems around the world. Challenges surrounding an overwhelming influx of patients with COVID-19 and changes in care dynamics prompt the need for care models and processes that optimize care in this medically complex patient population. The purpose of this report is to describe our institution's strategy to deploy pharmacy resources and standardize pharmacy processes to optimize the management of patients with COVID-19. METHODS: This retrospective, descriptive report characterizes documented pharmacy interventions in the acute care of patients admitted for COVID-19 during the period April 1 to April 15, 2020. Patient monitoring, interprofessional communication, and intervention documentation by pharmacy staff was facilitated through the development of a COVID-19-specific care bundle integrated into the electronic medical record. RESULTS: A total of 1,572 pharmacist interventions were documented in 197 patients who received a total of 15,818 medication days of therapy during the study period. The average number of interventions per patient was 8. The most common interventions were regimen simplification (15.9%), timing and dosing adjustments (15.4%), and antimicrobial therapy and COVID-19 treatment adjustments (15.2%). Patients who were admitted to an intensive care unit care at any point during their hospital stay accounted for 66.7% of all interventions documented. CONCLUSION: A pharmacy department's response to the COVID-19 pandemic was optimized through standardized processes. Pharmacists intervened to address a wide scope of medication-related issues, likely contributing to improved management of COVID-19 patients. Results of our analysis demonstrate the vital role pharmacists play as members of multidisciplinary teams during times of crisis.


Asunto(s)
Tratamiento Farmacológico de COVID-19 , Administración del Tratamiento Farmacológico/organización & administración , Farmacéuticos/organización & administración , Servicio de Farmacia en Hospital/organización & administración , Anciano , Anciano de 80 o más Años , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Antivirales/administración & dosificación , Antivirales/efectos adversos , COVID-19/epidemiología , Cuidados Críticos/organización & administración , Quimioterapia Combinada/efectos adversos , Quimioterapia Combinada/métodos , Electrólitos/administración & dosificación , Electrólitos/efectos adversos , Femenino , Mortalidad Hospitalaria , Humanos , Unidades de Cuidados Intensivos/organización & administración , Comunicación Interdisciplinaria , Masculino , Sistemas de Registros Médicos Computarizados/organización & administración , Persona de Mediana Edad , Pandemias/prevención & control , Rol Profesional , Estudios Retrospectivos , Resultado del Tratamiento
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