Dataset Information

Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics.

ABSTRACT:

Background

Bacterial pathogens cause substantial diarrhea morbidity and mortality among children living in endemic settings, yet antimicrobial treatment is only recommended for dysentery or suspected cholera.

Methods

AntiBiotics for Children with severe Diarrhea was a 7-country, placebo-controlled, double-blind efficacy trial of azithromycin in children 2-23 months of age with watery diarrhea accompanied by dehydration or malnutrition. We tested fecal samples for enteric pathogens utilizing quantitative polymerase chain reaction to identify likely and possible bacterial etiologies and employed pathogen-specific cutoffs based on genomic target quantity in previous case-control diarrhea etiology studies to identify likely and possible bacterial etiologies.

Results

Among 6692 children, the leading likely etiologies were rotavirus (21.1%), enterotoxigenic Escherichia coli encoding heat-stable toxin (13.3%), Shigella (12.6%), and Cryptosporidium (9.6%). More than one-quarter (1894 [28.3%]) had a likely and 1153 (17.3%) a possible bacterial etiology. Day 3 diarrhea was less common in those randomized to azithromycin versus placebo among children with a likely bacterial etiology (risk difference [RD]likely, -11.6 [95% confidence interval {CI}, -15.6 to -7.6]) and possible bacterial etiology (RDpossible, -8.7 [95% CI, -13.0 to -4.4]) but not in other children (RDunlikely, -0.3% [95% CI, -2.9% to 2.3%]). A similar association was observed for 90-day hospitalization or death (RDlikely, -3.1 [95% CI, -5.3 to -1.0]; RDpossible, -2.3 [95% CI, -4.5 to -.01]; RDunlikely, -0.6 [95% CI, -1.9 to .6]). The magnitude of risk differences was similar among specific likely bacterial etiologies, including Shigella.

Conclusions

Acute watery diarrhea confirmed or presumed to be of bacterial etiology may benefit from azithromycin treatment.

Clinical trials registration

NCT03130114.

SUBMITTER: Pavlinac PB

PROVIDER: S-EPMC11011181 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics.

Pavlinac Patricia B PB Platts-Mills James A JA Liu Jie J Atlas Hannah E HE Gratz Jean J Operario Darwin D Rogawski McQuade Elizabeth T ET Ahmed Dilruba D Ahmed Tahmeed T Alam Tahmina T Ashorn Per P Badji Henry H Bahl Rajiv R Bar-Zeev Naor N Chisti Mohammod Jobayer MJ Cornick Jen J Chauhan Aishwarya A De Costa Ayesha A Deb Saikat S Dhingra Usha U Dube Queen Q Duggan Christopher P CP Freyne Bridget B Gumbi Wilson W Hotwani Aneeta A Kabir Mamun M Islam Ohedul O Kabir Furqan F Kasumba Irene I Kibwana Upendo U Kotloff Karen L KL Khan Shaila S SS Maiden Victor V Manji Karim K Mehta Ashka A Ndeketa Latif L Praharaj Ira I Qamar Farah Naz FN Sazawal Sunil S Simon Jonathon J Singa Benson O BO Somji Sarah S Sow Samba O SO Tapia Milagritos D MD Tigoi Caroline C Toure Aliou A Walson Judd L JL Yousafzai Mohammad Tahir MT Houpt Eric R ER

The Journal of infectious diseases 20240401 4

<h4>Background</h4>Bacterial pathogens cause substantial diarrhea morbidity and mortality among children living in endemic settings, yet antimicrobial treatment is only recommended for dysentery or suspected cholera.<h4>Methods</h4>AntiBiotics for Children with severe Diarrhea was a 7-country, placebo-controlled, double-blind efficacy trial of azithromycin in children 2-23 months of age with watery diarrhea accompanied by dehydration or malnutrition. We tested fecal samples for enteric pathogens ...[more]

PMID: 37405406

Similar Datasets

Project description:BackgroundDue to the scarcity of published data on growth among children with severe diarrhoea requiring readmission during post-discharge follow-up, we aimed to investigate the potential impact of post-discharge readmission at day-90 follow-up on growth in diarrheal children aged 2-23 months.MethodsWe performed a secondary analysis using Bangladesh site data from the Antibiotic for Children with Diarrhea (ABCD) trial, a multi-country, randomised, double-blind, placebo-controlled study conducted from July 2017 to July 2019. Children aged 2-23 months who had severe diarrhoea defined as having acute diarrhoea with some/severe dehydration, or severe stunting, or moderate wasting, were admitted to the facility. In this analysis, we classified children who were re-hospitalised within a 90-day post-discharge follow-up period as cases and randomly selected controls who did not require re-hospitalisation, matching them by similar ages and sexes in a 1:3 ratio. We gathered anthropometric data on enrolment and day 90 follow-up. The outcome variables were changes in nutritional indicators height-for-age (ΔHAZ), weight-for-age (ΔWAZ), weight-for-height (ΔWHZ), and mid-upper arm circumference (ΔMUAC). We assessed for growth changes at day 90 post-discharge follow-up using multivariate linear regression.ResultsAmong 1431 diarrhoeal children enrolled, we identified 145 cases and 435 controls. In terms of the baseline admission characteristics, the cases were less likely to be immunised (81% vs. 72%; P = 0.031), vomit (11% vs. 22%; P = 0.001), and have dehydrating diarrhoea (26% vs. 36%; P = 0.026) than the controls. After adjusting for potential covariates, the cases had a significant reduction in growth than the controls at 90 days of post-discharge follow-up, according to anthropometric indices: ΔHAZ (β = -0.11; 95% confidence interval (CI) = -0.21, -0.01; P = 0.029), ΔWAZ (β = -0.24; 95% CI = -0.35, -0.14; P < 0.001), ΔWHZ (β = -0.25; 95% CI = -0.39, -0.12; P < 0.001), and ΔMUAC (for children 6-23 months, β = -0.17; 95% CI = -0.29, -0.04; P = 0.011).ConclusionsDiarrhoeal children aged 2-23 months requiring readmission during the 90-day post-discharge follow-up period had a significant deterioration of ponderal and linear growth, compared with those who did not require readmission. This finding underscores the importance of early identification of children with risks of post-discharge readmission and designing a package of post-discharge trials, including social and nutritional interventions that may help to reduce post-discharge readmissions as well as subsequent growth faltering.

Dataset Information

Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics.

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

Azithromycin for Bacterial Watery Diarrhea: A Reanalysis of the AntiBiotics for Children With Severe Diarrhea (ABCD) Trial Incorporating Molecular Diagnostics.

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