Single Dose Azithromycin to Prevent Cholera in Children

NCT04326478 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2020P000457
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether single-dose azithromycin is effective in preventing cholera in children who are at extremely high risk of infection. The study will also determine the effect of this intervention on the development of antibiotic resistant bacteria. The results will inform future strategies to prevent cholera in children, and improve overall understanding of the impact of azithromycin on antibiotic resistance.

Conditions

Cholera

Keywords

Cholera; Child Health

Outcome Measures

Primary Outcomes (1)

• Rate of V. cholerae infection in household contacts of cholera index cases

  The presence of V. cholerae O1 will be determined via the culturing of specimens collected via rectal swab sampling. Rectal swab acquisition will begin on the day of azithromycin administration and repeat on days 2, 3, 5, 6, and 7 following the intervention.

  57 months after enrollment of first subject

Secondary Outcomes (3)

• Duration of V. cholerae shedding

  50 months after enrollment of first subject

• Presence of any antibiotic or its metabolite detected by liquid chromatography-mass spectrometry (LC/MS) in the stool, beyond the assigned azithromycin intervention

  50 months after enrollment of first subject

• Rate of acquisition of antibiotic resistance following azithromycin treatment

  50 months after enrollment of first subject

Study Arms (2)

Azithromycin Group

EXPERIMENTAL

Enrolled children in a household randomized to the experimental group will receive a single weight-based dose of azithromycin administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera. They will then complete 9 follow-up study visits in their home, during which rectal swabs and/or stool samples will be collected.

Drug: Azithromycin

Non-antibiotic Placebo Group

PLACEBO COMPARATOR

Enrolled children in a household randomized to the placebo arm will receive a single dose of non-antibiotic placebo during their first study visit, which will occur within 12 hours of a member of their household testing positive for cholera. Like the participants in the intervention arm, they will complete 9 follow-up study visits in their home, during which rectal swabs and/or stool samples will be collected.

Biological: Placebo

Interventions

Azithromycin DRUG

Enrolled children in the intervention arm of this study will receive a single weight-based dose of azithromycin (20 mg/kg, to a maximum dose of 1 gram) administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera.

Azithromycin Group

Placebo BIOLOGICAL

Enrolled children in the placebo arm of this study will receive a single dose of non-antibiotic placebo administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera.

Non-antibiotic Placebo Group

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Shared cooking facilities for the prior three days with a household member who tested positive for cholera
• Age 1 to 15 years
• A parent or guardian available to provide informed consent
• Intention to remain enrolled in the study for 6 months

You may not qualify if:

• Participation in any other drug, device, or vaccine trial at present or within the past 30 days
• Known or suspected hypersensitivity to azithromycin or other macrolide antibiotics

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

icddr,b Dhaka hospital

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Cholera

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jason B Harris, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Pediatric Global Health, Associate Professor of Pediatrics, Harvard Medical School, Attending, Pediatric Infectious Diseases, Microbiology, Massachusetts General Hospital

Model Details: Each household will be randomized to either receive a single-dose of azithromycin or receive non-antibiotic placebo. All study visits after the drug administration, which occurs during the first visit, are equal for both groups.

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 30, 2020
• Study Start: October 31, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)