Evaluating in vivo effectiveness of sotrovimab for the treatment of Omicron subvariant BA.2 versus BA.1: a multicentre, retrospective cohort study.

Background: In vitro data suggested reduced neutralizing capacity of sotrovimab, a monoclonal antibody, against Omicron BA.2 subvariant. However, limited in vivo data exist regarding clinical effectiveness of sotrovimab for coronavirus disease 2019 (COVID-19) due to Omicron BA.

Respiratory viral infections including COVID-19 in solid organ transplantation.

Purpose Of Review: Respiratory viral infections are prevalent and contribute to significant morbidity and mortality among solid organ transplant (SOT) recipients. We review updates from literature on respiratory viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in the SOT recipient.

Recent Findings: With the wider availability and use of molecular diagnostic tests, our understanding of the epidemiology and impact of respiratory viruses in the SOT population continues to expand.

More Than a Decade Since the Latest CONSORT Non-inferiority Trials Extension: Do Infectious Diseases Trials Do Enough?

More than a decade after the Consolidated Standards of Reporting Trials group released a reporting items checklist for non-inferiority randomized controlled trials, the infectious diseases literature continues to underreport these items. Trialists, journals, and peer reviewers should redouble their efforts to ensure infectious diseases studies meet these minimum reporting standards.

Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antiretroviral Therapies: A Systematic Review.

Background: It is unclear whether the reporting quality of antiretroviral (ARV) noninferiority (NI) randomized controlled trials (RCTs) has improved since the CONSORT guideline release in 2006. The primary objective of this systematic review was assessing the methodological and reporting quality of ARV NI-RCTs. We also assessed reporting quality by funding source and publication year.

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles: A Systematic Review.

Importance: Randomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.

Objective: To assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.

Evidence Review: This systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021.

Prognostic factors for streptococcal toxic shock syndrome: systematic review and meta-analysis.

Objectives: To quantify the prognostic effects of demographic and modifiable factors in streptococcal toxic shock syndrome (STSS).

Design: Systematic review and meta-analysis.

Data Sources: MEDLINE, EMBASE and CINAHL from inception to 19 September 2022, along with citations of included studies.

sternal osteomyelitis following cardiac surgery: Case report and literature review.

Background: Sternal osteomyelitis caused by spp is uncommon in cardiac surgery patients requiring sternotomy.

Case Presentation: We report a 77-year-old male with a history of poorly controlled diabetes who was diagnosed with sternal osteomyelitis, three months following an uneventful coronary artery bypass surgery. He underwent multiple debridement surgeries and was treated with voriconazole.

What Is the Optimal Follow-up Length for Mortality in Bacteremia? Observations From a Systematic Review of Attributable Mortality.

Background: Deaths following bacteremia (SAB) may be related or unrelated to the infection. In SAB therapeutics research, the length of follow-up should be optimized to capture most attributable deaths and minimize nonattributable deaths. We performed a secondary analysis of a systematic review to describe attributable mortality in SAB over time.

Staphylococcus aureus bacteraemia mortality: a systematic review and meta-analysis.

Background: Precise estimates of mortality in Staphylococcus aureus bacteraemia (SAB) are important to convey prognosis and guide the design of interventional studies.

Objectives: We performed a systematic review and meta-analysis to estimate all-cause mortality in SAB and explore mortality change over time.

Data Sources: The MEDLINE and Embase databases, as well as the Cochrane Database of Systematic Reviews, were searched from January 1, 1991 to May 7, 2021.

How Generalizable Are Randomized Controlled Trials (RCTs) in Staphylococcus aureus Bacteremia? A Description of the Mortality Gap Between RCTs and Observational Studies.

In Staphylococcus aureus bacteremia, mortality rates in randomized controlled trials (RCTs) are consistently lower than observational studies. Stringent eligibility criteria and omission of early deaths in RCTs contribute to this mortality gap. Clinicians should acknowledge the possibility of a lower treatment effect when applying RCT results to bedside care.

Methodological and reporting quality of non-inferiority randomized controlled trials comparing antifungal therapies: a systematic review.

Background: Detailed reporting is essential in non-inferiority randomized controlled trials (NI-RCTs) to assess evidence quality, as these trials inform standards of care.

Objectives: The primary objective was to evaluate the methodological and reporting quality of antifungal NI-RCTs.

Data Sources: Medline, EMBASE, the Cochrane CENTRAL and the United States Federal Drug Administration (FDA) drugs database were searched to 9 September 2020.

In patients hospitalized for COVID-19, tocilizumab reduces mortality at 28 d.

WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Shankar-Hari M, Vale CL, Godolphin PJ, et al. JAMA. 2021;326:499-518.

Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?

Noninferiority randomized controlled trial (RCT) effectiveness may erode when results favor the active control over time and when a decreasingly effective control arm is used in serial trials. We analyzed 32 antifungal noninferiority RCTs (NI-RCTs) for these scenarios in this secondary analysis of a systematic review. Our exploratory analysis suggests that the erosion risk in the effectiveness of antifungal noninferiority trials is uncommon.

Confidence interval of risk difference by different statistical methods and its impact on the study conclusion in antibiotic non-inferiority trials.

Background: Numerous statistical methods can be used to calculate the confidence interval (CI) of risk differences. There is consensus in previous literature that the Wald method should be discouraged. We compared five statistical methods for estimating the CI of risk difference in terms of CI width and study conclusion in antibiotic non-inferiority trials.

Management of Prosthetic Joint Infection: 2 Cases and Literature Review.

Prosthetic joint infection caused by (TBPJI) is uncommon but can be encountered in immunocompromised patients or those from tuberculosis-endemic regions. A lack of clinical suspicion and experience with TBPJI often leads to a delay in diagnosis. We report 2 cases of TBPJI in a Hungarian-Canadian and Iranian-Canadian immigrant, respectively.

Intention-to-treat analysis may be more conservative than per protocol analysis in antibiotic non-inferiority trials: a systematic review.

Background: In non-inferiority trials, there is a concern that intention-to-treat (ITT) analysis, by including participants who did not receive the planned interventions, may bias towards making the treatment and control arms look similar and lead to mistaken claims of non-inferiority. In contrast, per protocol (PP) analysis is viewed as less likely to make this mistake and therefore preferable in non-inferiority trials. In a systematic review of antibiotic non-inferiority trials, we compared ITT and PP analyses to determine which analysis was more conservative.

Methodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antibiotic Therapies: A Systematic Review.

Background: Antibiotic noninferiority randomized controlled trials (RCTs) are used for approval of new antibiotics and making changes to antibiotic prescribing in clinical practice. We conducted a systematic review to assess the methodological and reporting quality of antibiotic noninferiority RCTs.

Methods: We searched MEDLINE, Embase, the Cochrane Database of Systematic Reviews, and the Food and Drug Administration drug database from inception until November 22, 2019, for noninferiority RCTs comparing different systemic antibiotic therapies.

Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review.

Novel antibiotics approved by noninferiority trials may become less effective over time in two scenarios: (i) the treatment effect in studies of novel antibiotics may be consistently worse than studies of older antibiotics; (ii) when a decreasingly effective control arm is used in a series of noninferiority trials. Our systematic review of 175 noninferiority antibiotic trials found these scenarios to be rare.