Quantitative sensory testing defines the trajectory of sensory neuropathy after severe COVID-19.

AIMS: To assess sensory neuropathy development after severe COVID-19. METHODS: Patients with severe COVID-19 underwent assessment of neuropathic symptoms, tendon reflexes, and quantitative sensory testing to evaluate vibration (VPT), cold (CPT), warm (WPT) and heat perception thresholds (HPT) within 1-3 weeks of admission and after 1-year. RESULTS: 32 participants with severe COVID-19 aged 68.6 ± 12.4 (18.8 % diabetes) were assessed. At baseline, numbness and neuropathic pain were present in 56.3 % and 43.8 % of participants, respectively. On the feet, VPT, WPT, and HPT were abnormal in 81.3 %, CPT was abnormal in 50.0 % and HPT on the face was abnormal in 12.5 % of patients. At 1-year follow-up, the prevalence of abnormal VPT (81.3 % vs 50.0 %, P < 0.01), WPT (81.3 % vs 43.8 %, P < 0.01), and HPT (81.3 % vs 50.0 %, P < 0.01) decreased, with no change in CPT (P = 0.21) on the feet or HPT on the face (P = 1.0). Only participants without diabetes recovered from an abnormal VPT, CPT, and WPT. Patients with long-COVID (37.5 %) had comparable baseline VPT, WPT and CPT with those without long-COVID (P = 0.07-0.69). CONCLUSIONS: Severe COVID-19 is associated with abnormal vibration and thermal thresholds which are sustained for up to 1 year in patients with diabetes. Abnormal sensory thresholds have no association with long-COVID development.

Long-term outcomes of patients following hospitalization for coronavirus disease 2019: a prospective observational study.

OBJECTIVES: Few data are available regarding follow up of patients with coronavirus disease 2019 (COVID-19) after their discharge. We aim to describe the long-term outcomes of survivors of hospitalization for COVID-19 followed up first at an outpatient facility and subsequently by telephone. METHODS: Observational prospective study conducted at a tertiary general hospital. Clinical and radiological progression was assessed and data were recorded on a standardized reporting form. Patients were divided into three groups according to Pao2/Fio2 at hospitalization: Pao2/Fio2 >300, Pao2/Fio2 300-200 and Pao2/Fio2 <200. A logistic multivariate regression model was performed to identify factors associated with persistence of symptoms. RESULTS: For facility follow up, 302 individuals were enrolled. Median follow up was 45 days after discharge; 78% (228/294) of patients had COVID-19-related symptoms (53% asthenia, 56% respiratory symptoms) and 40% (122/302) had residual pulmonary radiographic lesions. Pao2/Fio2 <200 was an independent predictor of persistent dyspnoea (OR 1.87, 95% CI 1.38-2.52, p < 0.0001). Pao2/Fio2 >300 was associated with resolution of chest radiographic lesions (OR 0.56, 95% CI 0.42-0.74, p < 0.0001). Fifty per cent of patients required specific medical follow up after the first consultation and were transferred to another physician. A total of 294 patients were contacted for telephone follow up after a median follow-up time of 7 months. Fifty per cent of patients (147/294) still presented symptoms and 49% (145/294) had psychological disorders. Asthenia was identified in 27% (78/294) and dyspnoea in 10% (28/294) of patients independently of Pao2/Fio2. CONCLUSIONS: Patients with COVID-19 require long-term follow up because of the persistence of symptoms; patients with low Pao2/Fio2 during the acute illness require special attention.

Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial-a trial protocol.

BACKGROUND: Community-acquired pneumonia (CAP) remains a leading cause of death worldwide, and hypoalbuminemia is associated with worse outcomes. However, it remains uncertain whether albumin administration could have any beneficial effects. We aim to assess whether the administration of albumin in hypoalbuminemic patients with CAP increases the proportion of clinically stable patients at day 5 compared with the standard of care alone. METHODS: This is a trial protocol for a superiority, non-blinded, multicenter, randomized, phase 3, interventional controlled clinical trial. The primary endpoint will be the proportion of clinical stable patients at day 5 (intention to treat), defined as those with stable vital signs for at least 24 h. The secondary endpoints will be time to clinical stability, duration of intravenous and total antibiotic treatment, length of hospital stay, intensive care unit admission, duration of mechanical ventilation and vasopressor treatment, adverse events, readmission within 30 days, and all-cause mortality. The trial has been approved by the Spanish Medicines and Healthcare Products Regulatory Agency. The investigators commit to publish the data in peer-reviewed journals within a year of the study completion date. Subjects will be recruited from three Spanish hospitals over a planned enrolment period of 2 years. A follow-up visit will be performed 1 month after discharge. We have estimated the need for a sample size of 360 patients at a two-sided 5% alpha-level with a power of 80% based on intention to treat. Eligible participants must be hospitalized, hypoalbuminemic (≤ 30 g/L), non-immunosuppressed, adults, and diagnosed with CAP. They will be randomly assigned (1:1) to receive standard care plus albumin (20 g in 100 mL) every 12 h for 4 days or standard care alone. DISCUSSION: If this randomized trial confirms the hypothesis, it should lead to a change in current clinical practice for the management of hypoalbuminemic patients with CAP. TRIAL REGISTRATION: European Clinical Trials Database (EudraCT) 2018-003117-18 . Registered on 12 April 2019. ClinicalTrials.gov NCT04071041 . Registered on 27 August 2019.

Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol.

INTRODUCTION: Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance and adverse events. We aim to test the hypothesis that comprehensive molecular testing, compared with routine microbiological testing, would be effective in reducing antibiotic use in patients with CAP. METHODS AND ANALYSIS: We will perform a randomised, controlled, open-label clinical trial with two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022. Non-severely immunosuppressed adults hospitalised for CAP will be considered eligible. Patients will be randomly assigned to receive either the experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing). The primary endpoint will be antibiotic consumption measured as days of antibiotic therapy per 1000 patient-days. Secondary endpoints will be de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death from any cause by 48 hours and 30 days after randomisation. We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of Bellvitge Hospital (AC028/19) and from the Spanish Medicines and Medical Devices Agency, and it is valid for all participating centres under existing Spanish legislation. Results will be presented at international meetings and will be made available to patients, their caregivers and funders. TRIAL REGISTRATION NUMBER: ClinicalTrials: NCT04158492. EudraCT: 2018-004880-29.

Influenza and Bacterial Coinfection in Adults With Community-Acquired Pneumonia Admitted to Conventional Wards: Risk Factors, Clinical Features, and Outcomes.

BACKGROUND: Relevance of viral and bacterial coinfection (VBC) in non-intensive care unit (ICU) hospitalized adults with community-acquired pneumonia (CAP) is poorly characterized. We aim to determine risk factors, features, and outcomes of VBC-CAP in this setting. METHODS: This is a prospective cohort of adults admitted to conventional wards with CAP. Patients were divided into VBC-CAP, viral CAP (V-CAP), and bacterial CAP (B-CAP) groups. Independent risk and prognostic factors for VBC-CAP were identified. RESULTS: We documented 1123 episodes: 57 (5.1%) VBC-CAP, 98 (8.7%) V-CAP, and 968 (86.1%) B-CAP. Patients with VBC-CAP were younger than those with B-CAP (54 vs 71 years; P < .001). Chronic respiratory disease was more frequent in patients with VBC-CAP than in those with V-CAP (26.3% vs 14.3%%; P = .001). Among those with influenza (n = 153), the VBC-CAP group received empirical oseltamivir less often (56.1% vs 73.5%; P < .001). Patients with VBC-CAP also had more respiratory distress (21.1% VBC-CAP; 19.4% V-CAP, and 9.8% B-CAP; P < .001) and required ICU admission more often (31.6% VBC-CAP, 31.6% V-CAP, and 12.8% B-CAP; P < .001). The 30-day case-fatality rate was 3.5% in the VBC-CAP group, 3.1% in the V-CAP group, and 6.3% in the B-CAP group (P = .232). Furthermore, VBC-CAP was associated with severity criteria (odds ratio [OR], 5.219; P < .001) and lack of empirical oseltamivir therapy in influenza cases (OR, 0.401; P < .043). CONCLUSIONS: Viral and bacterial coinfection-CAP involved younger patients with comorbidities and with poor influenza vaccination rate. Patients with VBC-CAP presented more respiratory complications and more often required ICU admission. Nevertheless, 30-day mortality rate was low and related either to severity criteria or to delayed initiation of oseltamivir therapy.

Non-intravenous carbapenem-sparing antibiotics for definitive treatment of bacteraemia due to Enterobacteriaceae producing extended-spectrum ß-lactamase (ESBL) or AmpC ß-lactamase: A propensity score study.

Carbapenems are considered the treatment of choice for extended-spectrum ß-lactamase (ESBL)- or AmpC ß-lactamase-producing Enterobacteriaceae bacteraemia. Data on the effectiveness of non-intravenous carbapenem-sparing antibiotic options are limited. This study compared the 30-day mortality and clinical failure associated with the use of carbapenems versus alternative non-intravenous antibiotics for the definitive treatment of ESBL/AmpC-positive Enterobacteriaceae bacteraemia. This 12-year retrospective study (2004-2015) included all patients with bacteraemia due to ESBL/AmpC-producing Enterobacteriaceae at a Spanish hospital. Given the lack of randomisation of initial therapies, a propensity score for receiving carbapenems was calculated. There were 1115 patients with a first episode of bacteraemia due to Escherichia coli or Klebsiella pneumoniae, of which 123 (11.0%) were ESBL/AmpC-positive. There were 101 eligible patients: 59 in the carbapenem group and 42 in the alternative treatment group (trimethoprim/sulfamethoxazole 59.5%, quinolones 21.4%). The most frequent sources of infection were urinary (63%) and biliary (15%). Compared with the carbapenem group, patients treated with an alternative regimen had a shorter hospital stay [median (IQR) 7 (5-10) days vs. 12 (9-18) days; P < 0.001]. Use of an alternative non-intravenous therapy did not increase mortality (OR = 0.27, 95% CI 0.05-1.61; P = 0.15). After controlling for confounding factors with the propensity score, the adjusted OR of carbapenem treatment was 4.95 (95% CI 0.94-26.01; P = 0.059). Alternative non-intravenous carbapenem-sparing antibiotics could have a role in the definitive treatment of ESBL/AmpC-positive Enterobacteriaceae bacteraemia, allowing a reduction in carbapenem use. Use of trimethoprim/sulfamethoxazole in this series showed favourable results.

Healthcare-Associated Mycobacterium bovis-Bacille Calmette-Guérin (BCG) Infection in Cancer Patients Without Prior BCG Instillation.

Background: Bacille Calmette-Guérin (BCG), an attenuated strain of Mycobacterium bovis, is widely used as adjunctive therapy for superficial bladder cancer. Intravesical administration of BCG has been associated with systemic infection. Disseminated infection due to M. bovis is otherwise uncommon. Methods: After identification of 3 patients with healthcare-associated BCG infection who had never received intravesical BCG administration, an epidemiologic study was performed. All patients with healthcare-associated BCG infection in the Barcelona tuberculosis (TB) program were reviewed from 1 January 2005 to 31 December 2015, searching for infections caused by M. bovis-BCG. Patients with healthcare-associated BCG infection who had not received intravesical BCG instillation were selected and the source of infection was investigated. Results: Nine oncology patients with infection caused by M. bovis-BCG were studied. All had permanent central venous catheters. Catheter maintenance was performed at 4 different outpatient clinics in the same room in which other patients underwent BCG instillations for bladder cancer without required biological precautions. All patients developed pulmonary TB, either alone or with extrapulmonary disease. Catheter-related infection was considered the mechanism of acquisition based on the epidemiologic association and positive catheter cultures for BCG in patients in whom mycobacterial cultures were performed. Conclusions: Physicians should be alerted to the possibility of TB due to nosocomially acquired, catheter-related infections with M. bovis-BCG in patients with indwelling catheters. This problem may be more common than expected in centers providing BCG therapy for bladder cancer without adequate precautions.

Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial.

BACKGROUND: The length of hospital stay (LOS) for community-acquired pneumonia (CAP) varies considerably, even though this factor has a major impact on the cost of care. We aimed to determine whether the use of a 3-step critical pathway is safe and effective in reducing duration of intravenous antibiotic therapy and length of stay in hospitalized patients with CAP. METHODS: We randomly assigned 401 adults who required hospitalization for CAP to follow a 3-step critical pathway including early mobilization and use of objective criteria for switching to oral antibiotic therapy and for deciding on hospital discharge or usual care. The primary end point was LOS. Secondary end points were the duration of intravenous antibiotic therapy, adverse drug reactions, need for readmission, overall case-fatality rate, and patients' satisfaction. RESULTS: Median LOS was 3.9 days in the 3-step group and 6.0 days in the usual care group (difference, -2.1 days; 95% CI, -2.7 to -1.7; P < .001). Median duration of intravenous antibiotic therapy was 2.0 days in the 3-step group and 4.0 days in the usual care group (difference, -2.0 days; 95% CI, -2.0 to -1.0; P < .001). More patients assigned to usual care experienced adverse drug reactions (4.5% vs 15.9% [difference, -11.4 percentage points; 95% CI, -17.2 to -5.6 percentage points; P < .001]). No significant differences were observed regarding subsequent readmissions, case fatality rate, and patients' satisfaction with care. CONCLUSIONS: The use of a 3-step critical pathway was safe and effective in reducing the duration of intravenous antibiotic therapy and LOS for CAP and did not adversely affect patient outcomes. Such a strategy will help optimize the process of care of hospitalized patients with CAP, and hospital costs would be reduced. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN17875607.

Comportamiento del personal de salud ante procedimientos médicos en personas seropositivas / Behaviour of health staff compared to medical procedures in seropoisitive persons

Se realizó por segundo año consecutivo un estudio descriptivo con el objetivo de determinar el comportamiento profesional del personal de salud en el Hospital Joaquín Paneca Consuegra, de Yaguajay, ante personas viviendo con VIH/SIDA, durante los meses de febrero y marzo del 2005-2006. El universo de estudio estuvo constituido por los 199 médicos y paramédicos que laboraron en el centro en el 2005, en comparación con el 2006 fue de 254. En ambos años se tomó una muestra aleatoria simple de 64 trabajadores. Se puede decir que todo el personal conoce como principal vía de transmisión la sexual, que aumentó la incidencia por la vía perinatal, no por la vía sanguínea. En cuanto a las normas de bioseguridad aplicadas en el hospital se demostró que no es significativo el aumento del personal que las desconoce; pero todavía queda un porciento que no tiene el nivel de conocimiento necesario ante la realización de procederes médicos. Se determinaron los porcientos de trabajadores que sintieron temor, los que consultarían cómo atender a esos pacientes enfermos y los que no los atenderían(AU)

On two consecutive years, a descriptive study was made to determine professional behaviour of health staff in Joaquín Paneca Consuegra Hospital in Yaguajay municipality in the case of persons carriers of HIV/AIDS during February and March 2005-2006. Study sample consisted of the 199 physicians and paramedical staff present in 2005 in this institution, compared to year 2006 was of 254 respectively. En both years, a simple randomized sample was obtained of 65 workers. It is possible to say that all staff knows as main transmission route,the sexual one, increasing incidence by means of the perinatal route, not by blood route. As regards biosecurity guidelines applied in hospital, it was possible to demonstrate that figure of staff unware of the above guidelines; but yet remains a percentage without the necessary knowledge level for the carrying-out of medical procedures. Percentage of fearful workers, those sought advise with regard to care of those patients, and those without this function(AU)

Comportamiento del personal de salud ante procedimientos médicos en personas seropositivas / Behaviour of health staff compared to medical procedures in seropoisitive persons

Se realizó por segundo año consecutivo un estudio descriptivo con el objetivo de determinar el comportamiento profesional del personal de salud en el Hospital “Joaquín Paneca Consuegra”, de Yaguajay, ante personas viviendo con VIH/SIDA, durante los meses de febrero y marzo del 2005-2006. El universo de estudio estuvo constituido por los 199 médicos y paramédicos que laboraron en el centro en el 2005, en comparación con el 2006 fue de 254. En ambos años se tomó una muestra aleatoria simple de 64 trabajadores. Se puede decir que todo el personal conoce como principal vía de transmisión la sexual, que aumentó la incidencia por la vía perinatal, no por la vía sanguínea. En cuanto a las normas de bioseguridad aplicadas en el hospital se demostró que no es significativo el aumento del personal que las desconoce; pero todavía queda un porciento que no tiene el nivel de conocimiento necesario ante la realización de procederes médicos. Se determinaron los porcientos de trabajadores que sintieron temor, los que consultarían cómo atender a esos pacientes enfermos y los que no los atenderían(AU)

On two consecutive years, a descriptive study was made to determine professional behaviour of health staff in “ Joaquín Paneca Consuegra” Hospital in Yaguajay municipality in the case of persons carriers of HIV/AIDS during February and March 2005-2006. Study sample consisted of the 199 physicians and paramedical staff present in 2005 in this institution, compared to year 2006 was of 254 respectively. En both years, a simple randomized sample was obtained of 65 workers. It is possible to say that all staff knows as main transmission route,the sexual one, increasing incidence by means of the perinatal route, not by blood route. As regards biosecurity guidelines applied in hospital, it was possible to demonstrate that figure of staff unware of the above guidelines; but yet remains a percentage without the necessary knowledge level for the carrying-out of medical procedures. Percentage of fearful workers, those sought advise with regard to care of those patients, and those without this function(AU)