Evidence map›Paper›PMID 35093029›Full record

Trial reportBMC infectious diseases2022

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.

Isatou Jagne, Alexander J Keeley, Abdoulie Bojang, Bully Camara, Edrissa Jallow, Elina Senghore, Claire Oluwalana, Saikou Y Bah, Claire E Turner, Abdul Karim Sesay and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2022. 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 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 18% 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
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Clinical microbiology reviews · 2024
    Review
  6. Article
  7. Article
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

14 authors at 3 institutions in 2 countries.

Isatou JagneDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Alexander J KeeleyDepartment of Molecular Biology and Biotechnology, University of Sheffield, Sheffield, UK.
Abdoulie BojangDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Bully CamaraDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Edrissa JallowDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Elina SenghoreDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Claire OluwalanaDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Saikou Y BahDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Claire E TurnerDepartment of Molecular Biology and Biotechnology, University of Sheffield, Sheffield, UK.
Abdul Karim SesayDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Umberto D'AlessandroDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Christian BottomleyDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Thushan I de SilvaDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia.
Anna RocaDisease Control and Elimination Theme, Medical Research Council Unit the Gambia at the London, School of Hygiene and Tropical Medicine, Banjul, The Gambia. aroca@mrc.gm.
MRC Unit the Gambia · GMUniversity of Sheffield · GBLondon School of Hygiene & Tropical Medicine · GB

Funding

Medical Research Council MR/R010161/1MRC UK and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement MR/J010391/1Royal Society & Wellcome Trust Royal Society & Wellcome Trust Sir Henry Dale Fellow (208765/Z/17/Z)The University of Sheffield HEFCE/ODA (155123)Wellcome TrustWellcome Trust Wellcome Trust Intermediate Clinical Fellowship (110058/Z/15/Z)
6 · The paper itself

Abstract

backgroundGroup A Streptococcus (GAS) is a major human pathogen and an important cause of maternal and neonatal sepsis. Asymptomatic bacterial colonization is considered a necessary step towards sepsis. Intra-partum azithromycin may reduce GAS carriage.

methodsA posthoc analysis of a double-blind, placebo-controlled randomized-trial was performed to determine the impact of 2 g oral dose of intra-partum azithromycin on maternal and neonatal GAS carriage and antibiotic resistance. Following screening, 829 mothers were randomized who delivered 843 babies. GAS was determined by obtaining samples from the maternal and newborn nasopharynx, maternal vaginal tract and breastmilk. Whole Genome Sequencing (WGS) of GAS isolates was performed using the Illumina Miseq platform.

resultsGAS carriage was lower in the nasopharynx of both mothers and babies and breast milk among participants in the azithromycin arm. No differences in GAS carriage were found between groups in the vaginal tract. The occurrence of azithromycin-resistant GAS was similar in both arms, except for a higher prevalence in the vaginal tract among women in the azithromycin arm. WGS revealed all macrolide-resistant vaginal tract isolates from the azithromycin arm were Streptococcus dysgalactiae subspecies equisimilis expressing Lancefield group A carbohydrate (SDSE(A)) harbouring macrolide resistant genes msr(D) and mef(A). Ten of the 45 GAS isolates (22.2%) were SDSE(A).

conclusionsOral intra-partum azithromycin reduced GAS carriage among Gambian mothers and neonates however carriage in the maternal vaginal tract was not affected by the intervention due to azithromycin resistant SDSE(A). SDSE(A) resistance must be closely monitored to fully assess the public health impact of intrapartum azithromycin on GAS. Trial registration ClinicalTrials.gov Identifier NCT01800942.

Indexed as

AzithromycinCarrier StateAnti-Bacterial AgentsFemaleGambiaHumansInfantInfant, NewbornStreptococcus pyogenesAnti-Bacterial AgentsAzithromycinAzithromycinBacterial carriageGroup A streptococcusStreptococcus dysgalactiae subspecies equisimilisSub-Saharan Africa

Identifiers

PMID35093029
PMCPMC8800276
OpenAlexW4220892312

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.