The edition · Infectious Diseases
Premixed vancomycin under recall, and a caesarean antibiotic that took eight years to reach four in ten operations
Two ready-to-use vancomycin presentations are under an ongoing Class II recall for manufacturing deviations. Plus what adoption of adjunctive azithromycin actually looked like, and a COVID trial that recruited 29 people.
The edition in brief
The infectious diseases desk today is mostly about delivery rather than discovery. Two ready-to-use vancomycin presentations, in sodium chloride and in dextrose, are under ongoing Class II recall for deviations from current good manufacturing practice. Class II means temporary or reversible harm is possible and serious harm unlikely, so this is a supply and preparation problem rather than a safety signal about vancomycin - but losing the premixed bag moves dilution back to the ward at the moment a septic patient needs the dose. An analysis of 1,663,441 US deliveries measured what happened after 2016 trial evidence that adjunctive azithromycin reduces postpartum infection at unscheduled caesarean. Administration rose from 2.2% to 39.6% of caesarean births, against essentially no change at vaginal birth: a difference-in-differences estimate of 37.6 percentage points (95% CI 33.1 to 42.2). Postpartum infection fell by an adjusted 2.0 percentage points (95% CI -2.6 to -1.4) relative to the vaginal birth trend. Eight years on, six in ten eligible operations still did not receive it. A phase 2 trial of transdermal 17β-estradiol for COVID-19 in Qatar was terminated in June 2022 having enrolled 29 men with mild disease against a much larger target, because vaccination and revised quarantine policy removed the eligible population. It reports tolerability and no thromboembolic events, and no efficacy conclusion is possible. An international trial of antibiotic-impregnated bone graft in hip arthroplasty is recruiting 1100 patients.
Ongoing Class II recall of ready-to-use vancomycin infusion bags
Check your premixed vancomycin stock against the recall, and if you have to prepare it on the ward, post the dilution and the maximum infusion rate at the bedside.
A COVID trial that recruited 29 of its target, and what it still reports
Nothing changes: this is a terminated feasibility trial reporting tolerability in 29 men, with no efficacy signal to act on.
Antibiotic-impregnated bone graft in hip arthroplasty goes to a 1100-patient trial
Nothing to act on yet; when it reports, read the organism and susceptibility data before the headline infection rate.
When a premix disappears, the error moves to whoever draws it up at 3am
Treat every antimicrobial presentation change as a clinical handover: write down the new concentration and rate, and brief the night team directly.
Adjunctive azithromycin at unscheduled caesarean: 40% uptake, and infection fell
Audit whether eligible unscheduled caesareans in your hospital actually receive adjunctive azithromycin, and treat under-use of indicated prophylaxis as a stewardship failure.
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