Evidence map›Paper›PMID 27026482›Full record

Trial reportClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2016

Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial.

A Roca, C Oluwalana, A Bojang, B Camara, B Kampmann, R Bailey, A Demba, C Bottomley, U D'Alessandro

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 44 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 6 pooled it
5.4field-weighted citation impact, top 5% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01800942 phase3completednot on this map

Prevention of Bacterial Infections in the Newborn by Pre-delivery Administration of Azithromycin (AZI): a Placebo-controlled Randomized Trial

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2013 to 2015Enrolled829ConditionsNeonatal InfectionArmsAzithromycin and Placebo
NCT03569904 unknown statusnot on this mapstarted 2018, after this paper: background citation

Markers of Pulmonary Dysbiosis Associated With Exacerbation in Patients Followed for Cystic Fibrosis

TypeobservationalSponsorUniversity Hospital, GrenobleRan2018 to 2021Enrolled30ConditionsCystic Fibrosis Pulmonary Exacerbation
NCT03871491 phase3completednot on this mapstarted 2020, after this paper: background citation

Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

TypeinterventionalSponsorNICHD Global Network for Women's and Children's HealthRan2020 to 2022Enrolled58,747ConditionsMaternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During LaborArmsAzithromycin, Placebo
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 6 syntheses or guidelines pooled it, 76 citations in OpenAlex.

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  3. β-Lactam-Resistant Streptococcus pneumoniae Dynamics Following Treatment: A Dose-Response Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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  7. Intrapartum oral azithromycin for maternal infection prophylaxis and the risk of postpartum hemorrhage: A secondary analysis of the A-PLUS trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
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  18. Impact of Intrapartum Oral Azithromycin on the Acquired Macrolide Resistome of Infants' Nasopharynx: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 3 countries.

A RocaMedical Research Council Unit The Gambia; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: aroca@mrc.gm.
C OluwalanaMedical Research Council Unit The Gambia.
A BojangMedical Research Council Unit The Gambia.
B CamaraMedical Research Council Unit The Gambia.
B KampmannMedical Research Council Unit The Gambia.
R BaileyLondon School of Hygiene and Tropical Medicine, London, UK.
A DembaMinistry of Health and Social Welfare, Gambia.
C BottomleyLondon School of Hygiene and Tropical Medicine, London, UK.
U D'AlessandroMedical Research Council Unit The Gambia; London School of Hygiene and Tropical Medicine, London, UK; Institute of Tropical Medicine, Antwerp, Belgium.
MRC Unit the Gambia · GMLondon School of Hygiene & Tropical Medicine · GBInstituut voor Tropische Geneeskunde · BEMinistry of Health and Social Welfare · GM

Funding

Medical Research Council MC_EX_MR/J010391/1Medical Research Council MC_UP_A900_1122Medical Research Council MR/K012126/1
6 · The paper itself

Abstract

Bacterial sepsis remains a leading cause of death among neonates with Staphylococcus aureus, group B streptococcus (GBS) and Streptococcus pneumoniae identified as the most common causative pathogens in Africa. Asymptomatic bacterial colonization is an intermediate step towards sepsis. We conducted a phase III, double-blind, placebo-controlled randomized trial to determine the impact of giving one oral dose of azithromycin to Gambian women in labour on the nasopharyngeal carriage of S. aureus, GBS or S. pneumoniae in the newborn at day 6 postpartum. Study participants were recruited in a health facility in western Gambia. They were followed for 8 weeks and samples were collected during the first 4 weeks. Between April 2013 and April 2014 we recruited 829 women who delivered 843 babies, including 13 stillbirths. Sixteen babies died during the follow-up period. No maternal deaths were observed. No serious adverse events related to the intervention were reported. According to the intent-to-treat analysis, prevalence of nasopharyngeal carriage of the bacteria of interest in the newborns at day 6 was lower in the intervention arm (28.3% versus 65.1% prevalence ratio 0.43; 95% CI 0.36-0.52, p <0.001). At the same time-point, prevalence of any bacteria in the mother was also lower in the azithromycin group (nasopharynx, 9.3% versus 40.0%, p <0.001; breast milk, 7.9% versus 21.6%, p <0.001; and the vaginal tract, 13.2% versus 24.2%, p <0.001). Differences between arms lasted for at least 4 weeks. Oral azithromycin given to women in labour decreased the carriage of bacteria of interest in mothers and newborns and may lower the risk of neonatal sepsis. Trial registrationClinicalTrials.gov Identifier NCT01800942.

Indexed as

AdolescentAdultAnti-Bacterial AgentsAzithromycinBacteriaBacterial InfectionsCarrier StateDouble-Blind MethodFemaleGambiaHumansInfantInfant, NewbornMaleMiddle AgedNasopharynxAnti-Bacterial AgentsAzithromycinPlacebosAzithromycinbacterial carriageneonatal sepsisrandomized clinical trialsub-Saharan Africa

Identifiers

PMID27026482
PMCPMC4936760
OpenAlexW2309376323

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.