Trial reportAntimicrobial agents and chemotherapy2015
Pharmacokinetics of Transfer of Azithromycin into the Breast Milk of African Mothers.
Trial report in Antimicrobial agents and chemotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01800942 (Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin), which is not on this map. Cited by 26 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial
Who cites it
26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Influential predictors of azithromycin pharmacokinetics: a systematic review of population pharmacokinetics.Annals of medicine · 2025Pooled it
- A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases.PLoS neglected tropical diseases · 2023Pooled it
- Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis.European journal of pediatrics · 2019Pooled it
- Adverse events in women and children who have received intrapartum antibiotic prophylaxis treatment: a systematic review.BMC pregnancy and childbirth · 2017Pooled it
- The efficacy of a single dose of oral azithromycin in labour to prevent infections in infants and birthing parents in Fiji: secondary outcomes from a randomised controlled trial.BMJ global health · 2026Trial
- Effect of intrapartum azithromycin on early childhood gut mycobiota development: post hoc analysis of a double-blind randomized trial.Nature communications · 2025Trial
- 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.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Effect of intra-partum azithromycin on the development of the infant nasopharyngeal microbiota: A post hoc analysis of a double-blind randomized trial.EBioMedicine · 2022Trial
- Impact of intra-partum azithromycin on carriage of group A streptococcus in the Gambia: a posthoc analysis of a double-blind randomized placebo-controlled trial.BMC infectious diseases · 2022Trial
- A Randomized Open-Label Evaluation of the Antimalarial Prophylactic Efficacy of Azithromycin-Piperaquine versus Sulfadoxine-Pyrimethamine in Pregnant Papua New Guinean Women.Antimicrobial agents and chemotherapy · 2019Trial
- Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2016Trial
- Clinical study design and modeling approaches to study secretion of drugs in human milk.Frontiers in pediatrics · 2026Review
- Transporters and drug secretion into human breast milk.Expert opinion on drug metabolism & toxicology · 2025Review
- A literature review of drug transport mechanisms during lactation.CPT: pharmacometrics & systems pharmacology · 2024Review
- Article
- Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk.Clinical pharmacokinetics · 2024Review
- Transfer of antibiotics and their metabolites in human milk: Implications for infant health and microbiota.Pharmacotherapy · 2023Review
- An untargeted metabolomics analysis of exogenous chemicals in human milk and transfer to the infant.Clinical and translational science · 2022Article
- Short-term increase in the carriage of azithromycin-resistantJAC-antimicrobial resistance · 2021Article
- Breastfeeding and Medication Use in Kidney Disease.Advances in chronic kidney disease · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 4 countries.
Funding
Abstract
Azithromycin (AZI) is used for its antibiotic and antimalarial properties in pregnancy. Reported estimates of AZI breast milk transfer, based on concentrations in mostly single samples from small numbers of women, have suggested that infant intake is safe. To better characterize infant intake and the associated potential benefits and risks, AZI was measured by liquid chromatography-mass spectrometry in four breast milk samples taken over 28 days postpartum from each of 20 Gambian women given 2 g AZI during labor. A population pharmacokinetic model utilizing published parameters for AZI disposition in pregnancy, the present breast milk concentrations, and increasing/decreasing sigmoid maximum-effect (Emax) functions adequately described temporal changes in the milk/plasma ratio. The median estimated absolute and relative cumulative infant doses were 4.5 mg/kg of body weight (95% prediction interval, 0.6 to 7.0 mg/kg) and 15.7% (95% prediction interval, 2.0 to 27.8%) of the maternal dose, respectively; the latter exceeded the recommended 10% safety limit. Although some infants with bacterial infections may benefit from AZI in breast milk, there is a risk of hypertrophic pyloric stenosis with a worst-case number needed to harm of 60 based on the present and available epidemiologic data. (This study has been registered at ClinicalTrials.gov under registration no. NCT01800942.).
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.