Antibiotic Stewardship
Randomized Clinical Trial: Dequalinium chloride demonstrates noninferiority to metronidazole in treating bacterial vaginosis – JAMA Netw Open
25 May, 2024 | 19:55h | UTCThis randomized clinical trial investigated the efficacy of dequalinium chloride compared to metronidazole for treating bacterial vaginosis in premenopausal women. Conducted across multiple centers from July 2021 to August 2022, the study involved 147 participants who were randomly assigned to receive either dequalinium chloride vaginal tablets or oral metronidazole. The primary outcome measured was the clinical cure rate shortly after treatment completion. Results showed that dequalinium chloride achieved a 92.8% cure rate, which was statistically noninferior to metronidazole’s 93.2% rate. Additionally, dequalinium chloride was better tolerated, with fewer adverse events reported compared to metronidazole. These findings suggest that dequalinium chloride is as effective as traditional antibiotic treatments for bacterial vaginosis and could be considered a viable non-antibiotic alternative due to its similar efficacy and enhanced tolerability.
Reference (link to free full-text):
RCT: No significant benefit of adjuvant prednisone for patients with cystic fibrosis with exacerbations unresponsive to antibiotics – Eur Respir J
6 May, 2024 | 06:32h | UTCThis randomized, double-blind, placebo-controlled trial investigated the effectiveness of adjuvant oral prednisone in enhancing lung function recovery in patients with cystic fibrosis (CF) experiencing pulmonary exacerbations (PExs) unresponsive to initial intravenous (IV) antibiotic treatment. The study involved 173 participants, with 76 not achieving more than 90% of their baseline forced expiratory volume in one second (ppFEV1) by Day 7 of antibiotic treatment and subsequently randomized to receive either oral prednisone (1 mg·kg−1 twice daily, up to 60 mg/day) or placebo for an additional 7 days. Results showed that 50% of the prednisone group and 39% of the placebo group recovered over 90% of their baseline ppFEV1 by Day 14. However, the difference was not statistically significant (11% difference; 95% CI -11, 34%; p=0.34). Additionally, prednisone did not significantly prolong the time to the next exacerbation compared to placebo. This study concludes that adjuvant oral prednisone does not significantly improve lung function recovery or delay subsequent exacerbations in CF patients not responding to initial antibiotic therapy.
Reference (link to abstract – $ for full-text):
RCT: Azithromycin fails to prevent moderate or severe chronic lung disease in preterm infants – Lancet Respir Med
6 May, 2024 | 06:28h | UTCThis randomized, placebo-controlled trial evaluated the effectiveness of azithromycin in preventing chronic lung disease (CLD) in preterm infants born at less than 30 weeks’ gestation across 28 UK neonatal intensive care units. A total of 799 infants were randomized to receive either intravenous azithromycin or a placebo. The primary outcome measured was survival without moderate or severe CLD at 36 weeks postmenstrual age. Results showed no significant difference between the azithromycin group (42% survival without CLD) and the placebo group (45% survival without CLD), with an adjusted odds ratio of 0.84 (95% CI 0.55–1.29, p=0.43). Pulmonary Ureaplasma spp colonization did not affect the treatment outcome. Given the lack of efficacy and the presence of several serious adverse events in the azithromycin group, the study concluded that azithromycin should not be recommended for preventing CLD in this population.
Reference (link to free full-text):
SCCM/IDSA Updated guidelines for evaluating new fever in adult ICU patients – Crit Care Med
5 May, 2024 | 15:12h | UTCThe 2023 revision of the guidelines for assessing new-onset fever in adult ICU patients stresses rigorous diagnostic processes using the GRADE methodology. These guidelines, developed without industry funding, offer 12 recommendations and nine best-practice statements focused primarily on the accurate measurement of core body temperature and initial diagnostic evaluations geared towards identifying potential infectious causes. Central temperature monitoring is recommended when possible; otherwise, oral or rectal measurements are preferred. The utility of imaging studies and rapid diagnostic tests is highlighted, along with the selective use of biomarkers to guide the cessation of antimicrobial therapy. The guidelines underscore that most recommendations are based on weak evidence, thus highlighting the need for continued research in diagnostic methodologies and fever management in the ICU setting.
Reference (link to free full-text):
Systematic Review: Comparing antibiotic treatment vs. appendectomy for the initial treatment of uncomplicated appendicitis – Cochrane Library
4 May, 2024 | 13:09h | UTCStudy Design and Population:
This Cochrane review analyzed 13 randomized controlled trials involving 3,358 participants to compare the efficacy of antibiotic treatment versus appendectomy in managing uncomplicated acute appendicitis. The included studies predominantly involved adult participants and utilized broad-spectrum antibiotics, with interventions ranging from open to predominantly laparoscopic appendectomy. Data collection spanned from hospital admission to up to seven years, with studies conducted across various global regions, including Asia, Europe, and North America.
Main Findings:
The primary outcomes revealed that antibiotic treatment might slightly increase the risk of unsuccessful treatment with 76 additional unsuccessful cases per 1,000 individuals compared to surgery, though these results did not reach clinical significance. Antibiotics reduced wound infections but possibly increased the average hospital stay by half a day. About 30.7% of participants treated with antibiotics required an appendectomy within one year. Secondary outcomes showed very uncertain evidence on antibiotics’ effect on intra-abdominal abscess or reoperation rates, and a slight increase in negative appendectomy rates was observed.
Implications for Practice:
The findings suggest that while antibiotics could serve as an initial treatment to avoid surgery in two-thirds of cases annually, a significant portion may still require surgical intervention. This information is crucial for clinicians in making informed treatment decisions, particularly considering patient preferences and the risk of surgery. Further research is needed to explore long-term outcomes and identify patient subgroups that may benefit most from either treatment.
Reference (link to abstract – $ for full-text):
M-A: Reduced risk of infective endocarditis following dental procedures with antibiotic prophylaxis in high-risk individuals
26 Apr, 2024 | 12:07h | UTCStudy Design and Population:
This systematic review and meta-analysis evaluated the impact of antibiotic prophylaxis on the incidence of infective endocarditis following invasive dental procedures. Researchers analyzed data from 1,152,345 cases sourced from PubMed, Cochrane-CENTRAL, Scopus, and other databases up to May 2023. The study included various research designs, such as case-control, cohort, and time-trend studies, assessing the effectiveness of antibiotic prophylaxis across different risk groups.
Main Findings:
The meta-analysis revealed that antibiotic prophylaxis significantly lowers the risk of infective endocarditis among individuals at high risk (pooled relative risk, 0.41; 95% CI, 0.29-0.57), with consistent findings across studies of good quality. However, the effectiveness of prophylaxis in individuals at moderate or low/unknown risk remains unsupported by sufficient evidence. Time-trend studies provided mixed results, with some indicating no change or an increase in infective endocarditis incidence post-guideline changes in 2007.
Implications for Practice:
The findings support the continued use of antibiotic prophylaxis for high-risk individuals undergoing invasive dental procedures, aligning with current guidelines from the American Heart Association and European Society of Cardiology. The lack of clear benefits in moderate and low-risk groups suggests a need for further research to optimize prophylaxis guidelines and ensure effective risk stratification in clinical practice.
Reference (link to abstract – $ for full-text):
FDA approves antibiotic Zevtera (ceftobiprole medocaril sodium) for three indications
26 Apr, 2024 | 11:39h | UTCThe FDA has granted approval for Zevtera (ceftobiprole medocaril sodium), an antibiotic formulated for injection, targeting three key bacterial infections. This includes treatment for adults with Staphylococcus aureus bloodstream infections (SAB) with or without right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in both adults and pediatric patients aged three months to under 18 years.
The approval follows rigorous clinical trials demonstrating Zevtera’s efficacy. In a multicenter study for SAB, Zevtera achieved a 69.8% success rate, slightly outperforming the comparator drug. For ABSSSI, Zevtera showed a 91.3% early clinical response, and for CABP, it had a clinical cure rate of 76.4% in adults. Pediatric efficacy for CABP was extrapolated from adult data and supported by a smaller pediatric trial.
Common side effects include anemia, nausea, and increased liver enzyme levels, with specific reactions varying by infection treated. Contraindications include severe hypersensitivity to ceftobiprole or other cephalosporins. Zevtera also carries warnings about potential hypersensitivity reactions, central nervous system effects, and Clostridioides difficile-associated diarrhea.
This approval, supported by Priority Review and Fast Track designations, offers a new treatment option for clinicians managing these serious infections.
Source: FDA NEWS RELEASE: FDA Approves New Antibiotic for Three Different Uses
Cohort Study: Inappropriate pneumonia diagnoses and associated risks in 17,290 hospitalized adults
26 Apr, 2024 | 11:25h | UTCStudy Design and Population:
This prospective cohort study analyzed medical records and patient interactions from July 2017 to March 2020 across 48 Michigan hospitals. A total of 17,290 adults admitted for general care were retrospectively assessed for community-acquired pneumonia (CAP) treatment, focusing on those who received antibiotics within the first two days of hospitalization.
Main Findings:
The study identified that 12.0% of the patients were inappropriately diagnosed with CAP. Key risk factors for misdiagnosis included older age, presence of dementia, and altered mental status at presentation. Among those misdiagnosed, 87.6% underwent a full course of antibiotics, which did not significantly change the 30-day risk of mortality, readmission, emergency visits, or Clostridioides difficile infections compared to brief treatment but was associated with higher antibiotic-related adverse events.
Implications for Practice:
The findings underscore the prevalence of inappropriate pneumonia diagnosis among hospitalized adults, especially in older patients with specific geriatric conditions. This study highlights the potential harms of unnecessary antibiotic use, suggesting a need for improved diagnostic accuracy and treatment decision-making in hospital settings to mitigate adverse outcomes.
Reference (free full-text):
RCT: Clarithromycin improves early clinical and inflammatory responses in hospitalized community-acquired pneumonia patients
23 Mar, 2024 | 20:25h | UTCStudy Design and Population: The ACCESS trial was a phase 3, prospective, double-blind, randomized controlled trial conducted in 18 Greek hospitals, involving adults hospitalized with community-acquired pneumonia who displayed systemic inflammatory response syndrome, had a Sequential Organ Failure Assessment (SOFA) score of 2 or more, and procalcitonin levels of 0.25 ng/mL or more. Participants were randomly assigned to receive either standard of care with intravenous cephalosporins or β-lactam/β-lactamase inhibitor combinations plus oral clarithromycin (500 mg twice daily for 7 days) or placebo. The trial aimed to evaluate the impact of clarithromycin on early clinical and inflammatory responses.
Main Findings: Among 278 participants allocated to clarithromycin (n=139) or placebo (n=139), the primary composite endpoint—indicating early clinical response and inflammatory burden reduction within 72 hours—was met by 68% of patients in the clarithromycin group compared to 38% in the placebo group, showcasing a significant difference (29.6%, odds ratio 3.40, p<0.0001). Serious treatment-emergent adverse events were slightly lower in the clarithromycin group than in the placebo group, although not statistically significant.
Implications for Practice: The addition of clarithromycin to the standard of care for hospitalized patients with community-acquired pneumonia significantly improves early clinical response and reduces inflammatory burden, potentially through modulation of the immune response. These results support the use of clarithromycin alongside β-lactam antibiotics in the treatment of community-acquired pneumonia, highlighting its role in enhancing patient outcomes by targeting early clinical and inflammatory indicators.
Reference
Prof Evangelos J Giamarellos-Bourboulis, MD et al. (2024). Clarithromycin for early anti-inflammatory responses in community-acquired pneumonia in Greece (ACCESS): a randomised, double-blind, placebo-controlled trial. The Lancet Respiratory Medicine, Volume(Issue), Pages. DOI: https://doi.org/10.1016/S2213-2600(23)00412-5. Access the study here: Link
Review | Artificial intelligence, machine learning and deep learning: Potential resources for the infection clinician
9 Aug, 2023 | 15:18h | UTC
Perspective | Cardiac device infection: removing barriers to timely and adequate treatment
4 Aug, 2023 | 11:54h | UTC
Position Paper | Perioperative antibiotic prophylaxis in skin surgery
3 Aug, 2023 | 13:39h | UTCPerioperative antibiotic prophylaxis in skin surgery – Position paper of the Antibiotic Stewardship working group of the German Society for Dermatologic Surgery (DGDC) – Journal of the German Society of Dermatology
Part 1: Procedure- and patient-related risk factors
Part 2: Special indications and situations
RCT | Early oral antibiotic switch in low-risk neutropenic sepsis shows mixed results
3 Aug, 2023 | 13:15h | UTC
Consensus Paper | Diagnosis and management of infective endocarditis in adults
1 Aug, 2023 | 14:34h | UTC
RCT | Limited antibiotic efficacy in children with sinusitis lacking nasopharyngeal pathogens
27 Jul, 2023 | 13:08h | UTCIdentifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial – JAMA (free for a limited period)
Editorial: Acute Bacterial Sinusitis: Limitations of Test-Based Treatment – JAMA (free for a limited period)
News Release: Bacterial testing in kids with sinusitis could slash antibiotic use – University of Pittsburgh
Commentary: Trial suggests bacterial test could reduce antibiotics in kids with sinusitis – CIDRAP
Commentary on Twitter
In children with acute sinusitis, antibiotic treatment had minimal benefit for those without nasopharyngeal bacterial pathogens. The antibiotic effect did not depend on the color of nasal discharge. https://t.co/hgRx1Qou53 pic.twitter.com/zYs8Mfbjjp
— JAMA (@JAMA_current) July 26, 2023
Cohort Study | 9.9% of patients acquire C. difficile carriage in healthcare facilities, most do not develop clinical infection
27 Jul, 2023 | 13:01h | UTC
Consensus Paper | Urinary tract infections in pregnant individuals
25 Jul, 2023 | 13:53h | UTCUrinary Tract Infections in Pregnant Individuals – Obstetrics & Gynecology
RCT | Long-term Doxycycline for COPD does not reduce exacerbations, except possibly in severe cases or with low eosinophils
24 Jul, 2023 | 12:50h | UTCA Double-Blind, Randomised, Placebo-controlled Trial of Long-Term Doxycycline Therapy on Exacerbation Rate in Patients with Stable COPD – American Journal of Respiratory and Critical Care Medicine (link to abstract – $ for full-text)
RCT | Molecular screening for bacterial vaginosis does not significantly reduce preterm birth rates
21 Jul, 2023 | 13:31h | UTCSee also: Visual Abstract
IDSA 2023 Guidance on the treatment of antimicrobial resistant gram-negative infections
20 Jul, 2023 | 11:15h | UTC
RCT | Direct oral challenge noninferior to skin testing followed by direct oral challenge in low-risk penicillin allergy patients
18 Jul, 2023 | 13:54h | UTCEfficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial – JAMA Internal Medicine (free for a limited period)
See also: Visual Abstract
News Release: World-first clinical trial to help millions with penicillin allergies – Vanderbilt University Medical Center
Commentary: Trial supports use of direct oral challenge for penicillin allergy – CIDRAP
Cohort study | Poor sensitivity of procalcitonin-on-admission for ruling out bloodstream infections in patients with suspected sepsis
18 Jul, 2023 | 13:39h | UTCReliability of Admission Procalcitonin Testing for Capturing Bacteremia Across the Sepsis Spectrum: Real-World Utilization and Performance Characteristics, 65 U.S. Hospitals, 2008–2017 – Critical Care Medicine (link to abstract – $ for full-text)
Guideline | Antibiotic therapy in patients with suspected antibiotic allergy
17 Jul, 2023 | 13:59h | UTC
Systematic Review | Criteria to achieve safe antimicrobial intravenous-to-oral switch in hospitalized adult populations
17 Jul, 2023 | 13:34h | UTC
Case Series | Cutibacterium acnes endocarditis often misdiagnosed due to absence of typical symptoms and delayed culture results
17 Jul, 2023 | 13:31h | UTC