Single Dose Azithromycin to Prevent Cholera in Children

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Brief Title

Single Dose Azithromycin to Prevent Cholera in Children

Official Title

Azithromycin Prophylaxis in Child Contacts of Cholera Patients: A Randomized Controlled Trial

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.
    

Detailed Description

      Vibrio cholerae causes 3 million cases of cholera and 100,000 deaths annually. An ongoing
      epidemic in Yemen has caused 1.7 million cases of cholera, with 58% of cholera-related deaths
      occurring in children. The World Health Organization (WHO) has targeted the elimination of
      cholera transmission by the year 2030, but the increasing burden of cholera suggests that
      more effective approaches are needed to prevent the disease. Access to safe water and
      sanitation and the use of oral cholera vaccines (OCV) are central to the WHO-proposed
      approach, but children remain particularly vulnerable. Children are at the highest risk of
      severe disease, and current cholera vaccines are ineffective in young children. In addition,
      natural disasters and human conflict often delay vaccination and other large-scale
      interventions.

      Effective antibiotics reduce the volume and duration of diarrhea in cholera by over 50% and
      bacterial shedding by 80%. They are recommended for the treatment of moderate to severe
      cholera. Due to limited data, there are no standards for the use of antibiotic prophylaxis
      for cholera, resulting in widely varied clinical practices and the frequent use of
      antibiotics with unproven efficacy. For this reason, the WHO Global Task Force on Cholera
      Control has prioritized research in this area, suggesting that further use of prophylactic
      antibiotics for cholera should be stopped until prospective studies designed to measure the
      effectiveness of antibiotic prophylaxis and its impact on antibiotic resistance can be
      conducted. This study will address these two knowledge gaps. This study will determine
      whether a single dose of azithromycin is effective in preventing V. cholerae infection in
      children, and evaluate the impact of its administration on antibiotic resistance in the gut.
      This study focuses on children because current OCVs are ineffective in young children and
      because children are at the highest risk of infection and mortality from cholera. While
      single-dose azithromycin is a preferred treatment for cholera, it has never been studied as
      prophylaxis. Azithromycin has also been shown to be safe and beneficial in other recent
      chemoprophylaxis studies in children.

      This is a double-blinded cluster randomized clinical trial of single-dose azithromycin to
      prevent cholera in children who are household contacts of a patient with cholera in Dhaka,
      Bangladesh. 920 children ages 1-15 years from 400 households in Dhaka, Bangladesh, who have
      shared cooking facilities for the prior three days with a household member with moderate to
      severe V. cholerae O1 infection, can participate in this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Duration of V. cholerae shedding

Condition

Cholera

Intervention

Azithromycin

Study Arms / Comparison Groups

 Azithromycin Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

920

Start Date

September 15, 2021

Completion Date

September 2026

Primary Completion Date

September 2025

Eligibility Criteria

        Inclusion criteria:

          -  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

        Exclusion criteria:

          -  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
      

Gender

All

Ages

1 Year - 15 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jason B Harris, MD, MPH, 617-643-5664, [email protected]



Administrative Informations


NCT ID

NCT04326478

Organization ID

2020P000457


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 International Centre for Diarrhoeal Disease Research, Bangladesh

Study Sponsor

Jason B Harris, MD, MPH, Principal Investigator, Massachusetts General Hospital


Verification Date

August 2021