CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,283 enrolled
Drug / intervention
Azithromycin Oral Product +5 moredrug
Likely dose
Azithromycin Oral Product 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03683667
NCT03683667Phase 3Completed
CompareCT.gov

Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 25, 2018·Updated Dec 5, 2022

In Brief

A Phase 3 clinical trial evaluating Azithromycin Oral Product, Placebos, and 4 other interventions for Stunting and 3 related conditions. Completed, enrolled 5,283 participants across 1 site.

Detailed Summary

This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStunting, Malnutrition; Protein, Enteric Pathogens, Campylobacter Infections
CountriesBangladesh
CollaboratorsInternational Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 25, 2018
Enrollment StartSep 23, 2018
Primary CompletionMar 19, 2020
Study CompletionMar 24, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.8 years ago

Interventions

Azithromycin Oral Productdrug

Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age

Placebosdrug

Contain inert excipients only

Protein Supplementdietary

Blended food providing 125 kcal and 10 g protein as egg white powder prepared as porridge and fed daily to infants from 6-12 months of age

Isocaloric Supplementdietary

Blended food providing 125 kcal and 1 g protein as rice powder prepared as porridge and fed daily to infants from 6-12 months of age

Eggdietary

Egg provided daily to infants from 6-12 months of age

Nutrition Educationbehavioral

Monthly messaging on infant and young child feeding