Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
Impact of Intrapartum Azithromycin on the Carriage and Antibiotic Resistance of Escherichia coli and Klebsiella pneumoniae in Mothers and Their Newborns: A Substudy of a Randomized, Double-Blind Trial Conducted in The Gambia and Burkina Faso.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03199547 (Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis and Death: a Phase III Double-blind Randomized Clinical Trial
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The role of breastfeeding in modulating antimicrobial resistance in neonates: a systematic review.Pediatric research · 2026Pooled it
- Cost-effectiveness of intrapartum azithromycin to prevent maternal infection, sepsis, or death in low-income and middle-income countries: a modelling analysis of data from a randomised, multicentre, placebo-controlled trial.The Lancet. Global health · 2025Trial
- Prenatal Azithromycin Exposure and Risk of Neurodevelopmental Disorders in Children.JAMA network open · 2026Article
- Transmission dynamics of Klebsiella pneumoniae in a neonatal intensive care unit in Zambia before and after an infection control bundle.PLOS global public health · 2026Article
- Associations between antibiotic exposure intensity, intestinal microbiome perturbations, and outcomes in premature neonates with bacteremia.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Article
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Authors and funding
21 authors.
Funding
Abstract
backgroundLimited data exist on the effects of intrapartum azithromycin on the prevalence of carriage and antibiotic resistance of Enterobacterales.
methodsWe conducted a randomized trial in The Gambia and Burkina Faso where women received intrapartum azithromycin (2 g) or placebo. We determined the impact of treatment on the prevalence of carriage and antibiotic resistance of Escherichia coli and Klebsiella pneumoniae by analyzing rectal swabs (RS), nasopharyngeal swabs (NPS), breast milk, and rectovaginal swabs (RVS). Bacteria were isolated microbiologically; antibiotic susceptibility was confirmed with an E-test. Prevalence ratios (PRs) with 95% confidence intervals (CIs) were used for comparison between arms.
resultsIn infants, E. coli carriage in RS was lower in the intervention than in the placebo arm at day 6 (63.0% vs 75.2%; PR, 0.84; 95% CI, .75-.95) and day 28 (52.7% vs 70.4%; 0.75; 0.64-0.87) post-intervention. Prevalence of azithromycin-resistant E. coli was higher in the azithromycin arm at day 6 (13.4% vs 3.6%; 3.75; 1.83-7.69) and day 28 (16.4% vs 9.6%; 1.71; 1.05-2.79). For K. pneumoniae, carriage in RS was higher in the intervention than in the placebo arm at day 6 (49.6% vs 37.2%, 1.33; 1.08-1.64) and day 28 (53.6% vs 32.9%, 1.63; 1.31-2.03). Prevalence of azithromycin-resistant K. pneumoniae was higher in the azithromycin arm at day 28 (7.3% vs 2.1%; 3.49; 1.30-9.37). No differences were observed for other sample types.
conclusionsIntrapartum azithromycin decreased E. coli carriage but increased both K. pneumoniae carriage and azithromycin resistance in both bacteria. These data need to be considered together with efficacy results to balance the potential short- and long-term impact of the intervention. Clinical Trials Registration. www.clinicaltrials.gov: NCT03199547.
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