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1.
Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med ; 30(s1): 1044-1049, 2022 Dec 15.
Article in Russian | MEDLINE | ID: covidwho-2117152

ABSTRACT

The review traces the evolution of the section on the use of antibacterial drugs in the temporary guidelines of the Ministry of Health for the treatment of a new coronavirus infection. Diagnostic approaches that play an important role in deciding on the need and duration of antibacterial therapy are presented. Routine use of fluoroquinolones should be restricted due to the adverse safety spectrum. According to existing data, the tactic of short courses of antibacterial therapy for community-acquired pneumonia are not inferior in effectiveness to longer courses. Unjustified prescribing of antibiotics increases the cost of medical care, promotes the selection of resistant pathogens and leads to adverse side effects. Timely updating of clinical recommendations, implementation of programs to control the appointment of antibacterial agents in medical organizations and strengthening the role of the clinical pharmacology service can reduce these adverse events.


Subject(s)
COVID-19 , Community-Acquired Infections , Pneumonia , Humans , COVID-19/drug therapy , Anti-Bacterial Agents/adverse effects , Community-Acquired Infections/drug therapy
2.
Clin Drug Investig ; 42(11): 921-935, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2094844

ABSTRACT

Macrolides such as azithromycin are commonly prescribed antibiotics during pregnancy. The good oral bioavailability and transplacental transfer of azithromycin make this drug suitable for the treatment of sexually transmitted diseases, toxoplasmosis, and malaria. Moreover, azithromycin is useful both in the management of preterm pre-labor rupture of membranes and in the adjunctive prophylaxis for cesarean delivery. The aim of this comprehensive narrative review is to critically analyze and summarize the available literature on the main aspects of azithromycin use in pregnant women, with a special focus on adverse offspring outcomes associated with prenatal exposure to the drug. References for this review were identified through searches of MEDLINE, PubMed, and EMBASE. Fetal and neonatal outcomes following prenatal azithromycin exposure have been investigated in several studies, yielding conflicting results. Increased risks of spontaneous miscarriage, major congenital malformations, cardiovascular malformations, digestive system malformations, preterm birth, and low birth weight have been reported in some studies but not in others. Currently, there is no conclusive evidence to support that azithromycin use by pregnant women causes adverse outcomes in their offspring. Therefore, this agent should only be used during pregnancy when clinically indicated, if the benefits of treatment are expected to outweigh the potential risks.


Subject(s)
Azithromycin , Premature Birth , Infant, Newborn , Pregnancy , Female , Humans , Azithromycin/adverse effects , Premature Birth/prevention & control , Premature Birth/drug therapy , Anti-Bacterial Agents/adverse effects
3.
Eur Respir Rev ; 31(166)2022 Dec 31.
Article in English | MEDLINE | ID: covidwho-2079388

ABSTRACT

Lower respiratory infections include acute bronchitis, influenza, community-acquired pneumonia, acute exacerbation of COPD and acute exacerbation of bronchiectasis. They are a major cause of death worldwide and often affect the most vulnerable: children, elderly and the impoverished. In this paper, we review the clinical presentation, diagnosis, severity assessment and treatment of adult outpatients with lower respiratory infections. The paper is divided into sections on specific lower respiratory infections, but we also dedicate a section to COVID-19 given the importance of the ongoing pandemic. Lower respiratory infections are heterogeneous entities, carry different risks for adverse events, and require different management strategies. For instance, while patients with acute bronchitis are rarely admitted to hospital and generally do not require antimicrobials, approximately 40% of patients seen for community-acquired pneumonia require admission. Clinicians caring for patients with lower respiratory infections face several challenges, including an increasing population of patients with immunosuppression, potential need for diagnostic tests that may not be readily available, antibiotic resistance and social aspects that place these patients at higher risk. Management principles for patients with lower respiratory infections include knowledge of local surveillance data, strategic use of diagnostic tests according to surveillance data, and judicious use of antimicrobials.


Subject(s)
Anti-Infective Agents , Bronchitis , COVID-19 , Community-Acquired Infections , Pneumonia , Respiratory Tract Infections , Adult , Child , Humans , Aged , Respiratory Tract Infections/diagnosis , Respiratory Tract Infections/drug therapy , Respiratory Tract Infections/epidemiology , Community-Acquired Infections/diagnosis , Community-Acquired Infections/drug therapy , Community-Acquired Infections/epidemiology , Bronchitis/diagnosis , Bronchitis/drug therapy , Pneumonia/diagnosis , Acute Disease , Anti-Infective Agents/therapeutic use , Hospitals , Anti-Bacterial Agents/adverse effects
5.
Gastroenterology ; 163(3): 608-619, 2022 09.
Article in English | MEDLINE | ID: covidwho-2008341

ABSTRACT

BACKGROUND & AIMS: Novel, effective treatments for Helicobacter pylori infection are needed. This study evaluated the efficacy of vonoprazan, a potassium-competitive acid blocker, vs standard treatment on H pylori eradication in the United States and Europe. METHODS: In a randomized, controlled, phase 3 trial, treatment-naïve adults with H pylori infection were randomized 1:1:1 to open-label vonoprazan dual therapy (20 mg vonoprazan twice daily; 1 g amoxicillin 3 times daily), or double-blind triple therapy twice a day (vonoprazan 20 mg or lansoprazole 30 mg; amoxicillin 1 g; clarithromycin 500 mg) for 14 days. The primary outcome was noninferiority in eradication rates in patients without clarithromycin- and amoxicillin-resistant strains (noninferiority margin = 10%). Secondary outcomes assessed superiority in eradication rates in clarithromycin-resistant infections, and in all patients. RESULTS: A total of 1046 patients were randomized. Primary outcome eradication rates (nonresistant strains): vonoprazan triple therapy 84.7%, dual therapy 78.5%, vs lansoprazole triple therapy 78.8% (both noninferior; difference 5.9%; 95% confidence interval [CI], -0.8 to 12.6; P < .001; difference -0.3%; 95% CI, -7.4 to 6.8; P = .007, respectively). Eradication rates in clarithromycin-resistant infections: vonoprazan triple therapy 65.8%, dual therapy 69.6%, vs lansoprazole triple therapy 31.9% (both superior; difference 33.9%; 95% CI, 17.7-48.1; P < .001; difference 37.7%; 95% CI, 20.5-52.6; P < .001, respectively). In all patients, vonoprazan triple and dual therapy were superior to lansoprazole triple therapy (80.8% and 77.2%, respectively, vs 68.5%, difference 12.3%; 95% CI, 5.7-18.8; P < .001; difference 8.7%; 95% CI, 1.9-15.4; P = .013). Overall frequency of treatment-emergent adverse events was similar between vonoprazan and lansoprazole regimens (P > .05). CONCLUSION: Both vonoprazan-based regimens were superior to proton pump inhibitor-based triple therapy in clarithromycin-resistant strains and in the overall study population. CLINICALTRIALS: gov; NCT04167670.


Subject(s)
Helicobacter Infections , Helicobacter pylori , Adult , Amoxicillin/adverse effects , Anti-Bacterial Agents/adverse effects , Clarithromycin/adverse effects , Drug Therapy, Combination , Helicobacter Infections/diagnosis , Helicobacter Infections/drug therapy , Humans , Lansoprazole/adverse effects , Proton Pump Inhibitors/adverse effects , Pyrroles , Sulfonamides , Treatment Outcome , United States/epidemiology
6.
Future Microbiol ; 17: 653-663, 2022 06.
Article in English | MEDLINE | ID: covidwho-1974548

ABSTRACT

Aim: To assess the impact of Clostridioides difficile infection on the course of COVID-19. Methods: The authors included 809 patients with COVID-19 in this retrospective study: 55 had C. difficile infection, 23 had C. difficile-negative antibiotic-associated diarrhea and 731 had no diarrhea. C. difficile in feces was determined by immunochromatographic test for its toxins. Results: C. difficile infection was associated with increased risk of death (hazard ratio = 2.6; p = 0.021), especially after 20 days of disease (hazard ratio = 6.5; p < 0.001). C. difficile infection-associated diarrhea was longer and more severe than C. difficile-negative antibiotic-associated diarrhea. Unlike patients with C. difficile-negative antibiotic-associated diarrhea, patients with C. difficile infection were admitted to the intensive care unit and needed mechanical ventilation more often than those without diarrhea. Conclusion: C. difficile infection worsens the course and prognosis of COVID-19.


Patients with COVID-19 usually receive antibiotic treatment, which predisposes them to antibiotic-associated diarrhea. In some cases, antibiotic-associated diarrhea can be caused by Clostridioides difficile bacteria. To learn more about the impact of C. difficile infection on COVID-19, the authors analyzed data from the medical records of 809 patients with COVID-19. The authors found that C. difficile co-infection worsens the course and prognosis of COVID-19. The authors suggest that patients with COVID-19 who develop diarrhea after taking antibiotics be tested for C. difficile and treated for this co-infection if the test is positive.


Subject(s)
COVID-19 , Clostridioides difficile , Clostridium Infections , Coinfection , Anti-Bacterial Agents/adverse effects , COVID-19/complications , Clostridium Infections/complications , Clostridium Infections/diagnosis , Clostridium Infections/epidemiology , Coinfection/drug therapy , Diarrhea/drug therapy , Humans , Retrospective Studies
8.
Pediatr Pulmonol ; 57(7): 1814-1817, 2022 07.
Article in English | MEDLINE | ID: covidwho-1913872

ABSTRACT

This pilot study successfully implemented a standardized protocol for tablet-based ototoxicity screening in pediatric cystic fibrosis (CF) patients exposed to aminoglycosides. Further studies are needed to assess the impact of implementation in a larger number of patients, as well as to determine barriers that may exist at centers with variation in available resources. This method of ototoxicity screening represents an accessible alternative to traditional audiology testing, and given the continued improvements in expected life span for people with CF, it is imperative that patients have regular access to this type of screening to allow for early identification of medication-related toxicities.


Subject(s)
Audiology , Cystic Fibrosis , Ototoxicity , Aminoglycosides/adverse effects , Anti-Bacterial Agents/adverse effects , Child , Cystic Fibrosis/drug therapy , Humans , Pharmacists , Pilot Projects
9.
Pediatr Allergy Immunol ; 33(6): e13809, 2022 06.
Article in English | MEDLINE | ID: covidwho-1909500

ABSTRACT

BACKGROUND: Mild non-immediate reactions (NIR) to beta-lactams (ßLs) are the most common manifestation of adverse drug reactions in children, and the drug provocation test (DPT) remains the gold standard for diagnosis. However, there are still controversies about the protocol that should be used, especially regarding the administration of doses and the DPT length. OBJECTIVE: This study aimed to evaluate a pediatric population with a history of mild NIR to amoxicillin (AMX) or to amoxicillin-clavulanic acid (AMX/CL) who underwent a diagnostic workup including a DPT with the culprit drug, to understand if a graded DPT or, instead, a single full dose could be the most appropriate way of administration in clinical practice. METHODS: The data of children were retrospectively analyzed for a 5-year period, with demographic and clinical characteristics collected. We reported the allergy workup and the results of the DPT performed with the administration of incremental doses and a prolonged DPT at home for a total of 5 days. RESULTS: Three hundred fifty-four patients were included. Overall, 23/354 (6.5%) DPTs were positive: 11/23 patients showed a reaction after 2-8 h after the last dose on the 1st or 2nd day (1 reacted 30 min after the last dose), 1/23 reacted with urticaria 30 min after the first dose, 11/23 reacted at home on the 5th day of the DPT. CONCLUSION: This paper indirectly suggests that a single therapeutic dose administered on the 1st day of a DPT could be safe in the diagnostic workup of mild NIR to AMX/CL. Moreover, this could be less time-consuming as patients would spend less time in the hospital, also considering the public health restrictions imposed during the COVID-19 pandemic.


Subject(s)
COVID-19 , Drug Hypersensitivity , Amoxicillin/adverse effects , Anti-Bacterial Agents/adverse effects , Child , Drug Hypersensitivity/diagnosis , Humans , Pandemics , Retrospective Studies , Skin Tests/methods , Tertiary Healthcare
10.
JAMA Pediatr ; 176(3): 253-261, 2022 Mar 01.
Article in English | MEDLINE | ID: covidwho-1864300

ABSTRACT

IMPORTANCE: Childhood community-acquired pneumonia (CAP) is usually treated with 10 days of antibiotics. Shorter courses may be effective with fewer adverse effects and decreased potential for antibiotic resistance. OBJECTIVE: To compare a short (5-day) vs standard (10-day) antibiotic treatment strategy for CAP in young children. DESIGN, SETTING, AND PARTICIPANTS: Randomized double-blind placebo-controlled clinical trial in outpatient clinic, urgent care, or emergency settings in 8 US cities. A total of 380 healthy children aged 6 to 71 months with nonsevere CAP demonstrating early clinical improvement were enrolled from December 2, 2016, to December 16, 2019. Data were analyzed from January to September 2020. INTERVENTION: On day 6 of their originally prescribed therapy, participants were randomized 1:1 to receive 5 days of matching placebo or 5 additional days of the same antibiotic. MAIN OUTCOMES AND MEASURES: The primary end point was the end-of-treatment response adjusted for duration of antibiotic risk (RADAR), a composite end point that ranks each child's clinical response, resolution of symptoms, and antibiotic-associated adverse effects in an ordinal desirability of outcome ranking (DOOR). Within each DOOR rank, participants were further ranked by the number of antibiotic days, assuming that shorter antibiotic durations were more desirable. Using RADAR, the probability of a more desirable outcome was estimated for the short- vs standard-course strategy. In a subset of children, throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. RESULTS: A total of 380 children (189 randomized to short course and 191 randomized to standard course) made up the study population. The mean (SD) age was 35.7 (17.2) months, and 194 participants (51%) were male. Of the included children, 8 were Asian, 99 were Black or African American, 234 were White, 32 were multiracial, and 7 were of unknown or unreported race; 33 were Hispanic or Latino, 344 were not Hispanic or Latino, and 3 were of unknown or unreported ethnicity. There were no differences between strategies in the DOOR or its individual components. Fewer than 10% of children in either strategy had an inadequate clinical response. The short-course strategy had a 69% (95% CI, 63-75) probability of a more desirable RADAR outcome compared with the standard-course strategy. A total of 171 children were included in the resistome analysis. The median (range) number of antibiotic resistance genes per prokaryotic cell (RGPC) was significantly lower in the short-course strategy compared with the standard-course strategy for total RGPC (1.17 [0.35-2.43] vs 1.33 [0.46-11.08]; P = .01) and ß-lactamase RGPC (0.55 [0.18-1.24] vs 0.60 [0.21-2.45]; P = .03). CONCLUSIONS AND RELEVANCE: In this study, among children responding to initial treatment for outpatient CAP, a 5-day antibiotic strategy was superior to a 10-day strategy. The shortened approach resulted in similar clinical response and antibiotic-associated adverse effects, while reducing antibiotic exposure and resistance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02891915.


Subject(s)
Community-Acquired Infections , Pneumonia , Anti-Bacterial Agents/adverse effects , Child , Child, Preschool , Community-Acquired Infections/drug therapy , Double-Blind Method , Female , Humans , Male , Outpatients , Pneumonia/drug therapy
11.
Antimicrob Resist Infect Control ; 11(1): 74, 2022 05 21.
Article in English | MEDLINE | ID: covidwho-1862157

ABSTRACT

BACKGROUND: Patients hospitalised for COVID-19 may present with or acquire bacterial or fungal infections that can affect the course of the disease. The aim of this study was to describe the microbiological characteristics of laboratory-confirmed infections in hospitalised patients with severe COVID-19. METHODS: We reviewed the hospital charts of a sample of patients deceased with COVID-19 from the Italian National COVID-19 Surveillance, who had laboratory-confirmed bacterial or fungal bloodstream infections (BSI) or lower respiratory tract infections (LRTI), evaluating the pathogens responsible for the infections and their antimicrobial susceptibility. RESULTS: Among 157 patients with infections hospitalised from February 2020 to April 2021, 28 (17.8%) had co-infections (≤ 48 h from admission) and 138 (87.9%) had secondary infections (> 48 h). Most infections were bacterial; LRTI were more frequent than BSI. The most common co-infection was pneumococcal LRTI. In secondary infections, Enterococci were the most frequently recovered pathogens in BSI (21.7% of patients), followed by Enterobacterales, mainly K. pneumoniae, while LRTI were mostly associated with Gram-negative bacteria, firstly Enterobacterales (27.4% of patients, K. pneumoniae 15.3%), followed by A. baumannii (19.1%). Fungal infections, both BSI and LRTI, were mostly due to C. albicans. Antibiotic resistance rates were extremely high in Gram-negative bacteria, with almost all A. baumannii isolates resistant to carbapenems (95.5%), and K. pneumoniae and P. aeruginosa showing carbapenem resistance rates of 59.5% and 34.6%, respectively. CONCLUSIONS: In hospitalised patients with severe COVID-19, secondary infections are considerably more common than co-infections, and are mostly due to Gram-negative bacterial pathogens showing a very high rate of antibiotic resistance.


Subject(s)
Anti-Bacterial Agents , Bacteremia , COVID-19 , Coinfection , Drug Resistance, Microbial , Fungemia , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Bacteremia/complications , Bacteremia/drug therapy , Bacteremia/microbiology , COVID-19/complications , Coinfection/drug therapy , Coinfection/epidemiology , Coinfection/microbiology , Fungemia/complications , Fungemia/drug therapy , Fungemia/microbiology , Hospitalization/statistics & numerical data , Humans , Italy/epidemiology , Population Surveillance , Respiratory Tract Infections/complications , Respiratory Tract Infections/drug therapy , Respiratory Tract Infections/microbiology , Respiratory Tract Infections/virology
12.
Trials ; 23(1): 427, 2022 May 21.
Article in English | MEDLINE | ID: covidwho-1849770

ABSTRACT

BACKGROUND: Inappropriate antibiotic use can cause harm and promote antimicrobial resistance, which has been declared a major health challenge by the World Health Organization. In Australian residential aged care facilities (RACFs), the most common indications for antibiotic prescribing are for infections of the urinary tract, respiratory tract and skin and soft tissue. Studies indicate that a high proportion of these prescriptions are non-compliant with best prescribing guidelines. To date, a variety of interventions have been reported to address inappropriate prescribing and overuse of antibiotics but with mixed outcomes. This study aims to identify the impact of a set of sustainable, multimodal interventions in residential aged care targeting three common infection types. METHODS: This protocol details a 20-month stepped-wedge cluster-randomised trial conducted across 18 RACFs (as 18 clusters). A multimodal multi-disciplinary set of interventions, the 'AMS ENGAGEMENT bundle', will be tailored to meet the identified needs of participating RACFs. The key elements of the intervention bundle include education for nurses and general practitioners, telehealth support and formation of an antimicrobial stewardship team in each facility. Prior to the randomised sequential introduction of the intervention, each site will act as its own control in relation to usual care processes for antibiotic use and stewardship. The primary outcome for this study will be antibiotic consumption measured using defined daily doses (DDDs). Cluster-level rates will be calculated using total occupied bed numbers within each RACF during the observation period as the denominator. Results will be expressed as rates per 1000 occupied bed days. An economic analysis will be conducted to compare the costs associated with the intervention to that of usual care. A comprehensive process evaluation will be conducted using the REAIM Framework, to enable learnings from the trial to inform sustainable improvements in this field. DISCUSSION: A structured AMS model of care, incorporating targeted interventions to optimise antimicrobial use in the RACF setting, is urgently needed and will be delivered by our trial. The trial will aim to empower clinicians, residents and families by providing a robust AMS programme to improve antibiotic-related health outcomes. TRIAL REGISTRATION: US National Library of Medicine Clinical Trials.gov ( NCT04705259 ). Prospectively registered in 12th of January 2021.


Subject(s)
Anti-Infective Agents , Antimicrobial Stewardship , Aged , Anti-Bacterial Agents/adverse effects , Anti-Infective Agents/adverse effects , Antimicrobial Stewardship/methods , Australia , Humans , Inappropriate Prescribing/prevention & control , Randomized Controlled Trials as Topic
13.
Am J Health Syst Pharm ; 79(Suppl 2): S43-S52, 2022 05 24.
Article in English | MEDLINE | ID: covidwho-1830988

ABSTRACT

PURPOSE: Current literature surrounding management of patients with reported ß-lactam allergies focuses on allergy delabeling. Standard clinical decision support tools have not been optimized to be compatible with the currently accepted cross-reaction rate of 1% to 2%. This potentially promotes use of non-ß-lactam antibiotics, which are often not first-line therapy and may carry increased risks. The impact of electronic medical record (EMR) clinical decision support tool optimization on utilization of ß-lactam antibiotics in ß-lactam-allergic patients was evaluated. METHODS: A retrospective pre-post ß-lactam cross-allergy EMR alert suppression quality improvement intervention cohort study of ß-lactam-allergic adult inpatients prescribed antibiotics was conducted. Preintervention baseline data were collected for an initial cohort admitted during September 2018. The intervention, in which clinical decision support rules were updated to display ß-lactam cross-sensitivity allergy alerts only for ß-lactam-allergic patients with documentation of organization-defined high-severity reactions of anaphylaxis, hives, and shortness of breath, was implemented August 20, 2019. The postintervention cohort included patients admitted during September 2019. RESULTS: A 91% increase in the percentage of ß-lactam-allergic patients who received a ß-lactam agent at any time during their admission was noted after the intervention (26.6% vs 51%, P < 0.001). Statistically significant decreases in prescribing of alternative antibiotic classes were seen for fluoroquinolones (decrease from 45.3% to 26%, P < 0.001), aminoglycosides (decrease from 9.4% to 2.9%, P = 0.002), and aztreonam (decrease from 30% to 16.7%, P < 0.001). CONCLUSION: EMR ß-lactam cross-allergy alert optimization consistent with current literature significantly improved the utilization of alternative ß-lactam subclasses, mostly through ß-lactam prescribing as initial therapy in ß-lactam-allergic patients.


Subject(s)
Drug Hypersensitivity , beta-Lactams , Adult , Anti-Bacterial Agents/adverse effects , Cohort Studies , Drug Hypersensitivity/diagnosis , Drug Hypersensitivity/epidemiology , Drug Hypersensitivity/prevention & control , Electronic Health Records , Humans , Penicillins , Retrospective Studies , beta-Lactams/adverse effects
14.
J Anesth ; 36(3): 432-435, 2022 06.
Article in English | MEDLINE | ID: covidwho-1826493

ABSTRACT

Prolonged neurological symptoms such as "brain fog" and cognitive impairment have occurred after coronavirus disease 2019 (COVID-19) infection. In this report, we describe impaired consciousness caused by cefepime hydrochloride (CFPM) in a patient with cognitive sequalae of COVID-19. A 56-year-old male patient was diagnosed with penile abscess after COVID-19 infection, and a blood culture detected two drug-resistant Pseudomonas aeruginosa strains. Therefore, CFPM 2 g × twice/day was administered on day 71 after intensive care unit admission. Approximately 48 h after CFPM administration, the patient showed disturbances in consciousness. Contrast-enhanced computed tomography, magnetic resonance imaging, and spinal fluid examination revealed no obvious abnormalities. Therefore, CFPM-induced neurotoxicity was suspected. CFPM was discontinued and ceftazidime 2 g × three times/day was initiated. The patient's consciousness improved 30 h after the final administration of CFPM. Serum CFPM concentrations were 14.2, 21.7, 21.7, and 11.9 µg/mL on days 1, 2, and 3 after the initiation of CFPM and on the day after CFPM was discontinued, respectively. In conclusion, intensivists should pay attention to new neurological symptoms such as CFPM-induced encephalopathy in patients with prolonged neurological symptoms after COVID-19 infection.


Subject(s)
Brain Diseases , COVID-19 , Anti-Bacterial Agents/adverse effects , Brain Diseases/chemically induced , Brain Diseases/diagnostic imaging , COVID-19/complications , COVID-19/drug therapy , Cefepime/adverse effects , Cephalosporins/adverse effects , Humans , Male , Middle Aged
15.
Br J Dermatol ; 187(1): 12-20, 2022 07.
Article in English | MEDLINE | ID: covidwho-1788834

ABSTRACT

The spread of COVID-19 serves as a reminder of the might of microbes in the era of modern medicine. For years, another threat has preoccupied infectious disease experts and public health officials alike: rising antimicrobial resistance (AMR). Resistance is exceeding stewardship efforts as well as the rates of new drug development and approval in the market. A dry antimicrobial pipeline is threatening regression to a preantibiotic era. While the consequences of resistance may seem far removed from daily clinical practice, awareness of AMR is essential to dermatological care given that dermatologists prescribe more antibiotics per physician than other providers. Antibiotics in dermatology are often used for prolonged courses, with significant potential for microbiome alteration and antibiotic-related adverse effects. Through this review we hope to contribute to efforts of bringing the crisis of AMR to the forefront of daily dermatological practice.


Subject(s)
Anti-Infective Agents , Bacterial Infections , COVID-19 , Anti-Bacterial Agents/adverse effects , Bacteria , Drug Resistance, Bacterial , Humans
16.
Pharmacol Res Perspect ; 10(2): e00931, 2022 04.
Article in English | MEDLINE | ID: covidwho-1782680

ABSTRACT

The aim of this study was to estimate healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions in Finland from 2008 to 2019. Serious adverse reaction types were identified from the Finnish Pharmaceutical Insurance Pool's pharmaceutical injury claims and the Finnish Medicines Agency's Adverse Reaction Register. A decision tree model was built to predict costs and mortality associated with serious adverse drug reactions (ADR). Severe clostridioides difficile infections, severe cutaneous adverse reactions, tendon ruptures, aortic ruptures, and liver injuries were included as serious adverse drug reactions in the model. Direct healthcare costs of a serious ADR were based on the number of reimbursed fluoroquinolone prescriptions from the Social Insurance Institution of Finland's database. Sensitivity analyses were conducted to address parameter uncertainty. A total of 1 831 537 fluoroquinolone prescriptions were filled between 2008 and 2019 in Finland, with prescription numbers declining 40% in recent years. Serious ADRs associated with fluoroquinolones lead to estimated direct healthcare costs of 501 938 402 €, including 11 405 ADRs and 3,884 deaths between 2008 and 2019. The average mortality risk associated with the use of fluoroquinolones was 0.21%. Severe clostridioides difficile infections were the most frequent, fatal, and costly serious ADRs associated with the use of fluoroquinolones. Although fluoroquinolones continue to be generally well-tolerated antimicrobials, serious adverse reactions cause long-term impairment to patients and high healthcare costs. Therefore, the risks and benefits should be weighed carefully in antibiotic prescription policies, as well as with individual patients.


Subject(s)
Anti-Bacterial Agents/adverse effects , Fluoroquinolones/adverse effects , Health Care Costs/statistics & numerical data , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Anti-Bacterial Agents/economics , Databases, Factual/statistics & numerical data , Decision Trees , Drug-Related Side Effects and Adverse Reactions/economics , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/mortality , Finland , Fluoroquinolones/economics , Humans , Retrospective Studies
17.
J Infect Chemother ; 28(3): 465-468, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1778294

ABSTRACT

Dalbavancin is a lipoglycopeptide antibiotic used off-label to treat serious gram-positive infections, including infections secondary to methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin has unique pharmacokinetic parameters and has a role in therapy for treating vulnerable patients, including intravenous drug users, who have challenges complying with typical care plans for serious infections. While there is data indicating successful clinical use of dalbavancin in patients with history of intravenous drug use as well as pharmacokinetic-pharmacodynamic data assessing dalbavancin in obesity, there is a lack of information regarding clinical effects of dalbavancin in patients with extreme obesity, especially in patients with concomitant drug use. This case report describes a 40-year-old morbidly obese female actively using intravenous drugs who developed prolonged MRSA bacteremia without a recognizable focus. Despite partial treatment with dalbavancin, the patient developed osteomyelitis and discitis of the spine with associated epidural phlegmon, likely complications of the MRSA bacteremia.


Subject(s)
Bacteremia , Methicillin-Resistant Staphylococcus aureus , Obesity, Morbid , Adult , Anti-Bacterial Agents/adverse effects , Bacteremia/drug therapy , Female , Humans , Obesity, Morbid/complications , Obesity, Morbid/drug therapy , Teicoplanin/adverse effects , Teicoplanin/analogs & derivatives
18.
N Engl J Med ; 386(14): 1327-1338, 2022 04 07.
Article in English | MEDLINE | ID: covidwho-1778677

ABSTRACT

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.).


Subject(s)
Anti-Bacterial Agents , Carbapenems , Pyelonephritis , Urinary Tract Infections , Administration, Intravenous , Administration, Oral , Adult , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/therapeutic use , Carbapenems/administration & dosage , Carbapenems/adverse effects , Carbapenems/therapeutic use , Double-Blind Method , Drug Resistance, Multiple, Bacterial , Ertapenem/administration & dosage , Ertapenem/adverse effects , Ertapenem/therapeutic use , Humans , Pyelonephritis/drug therapy , Urinary Tract Infections/drug therapy , Urinary Tract Infections/microbiology
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