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One dose, big hope: antibiotic may stop cholera in kids

NCT ID NCT04326478

Prevention Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether giving children a single dose of the antibiotic azithromycin right after a household member tests positive for cholera can prevent them from getting infected. The study enrolls children aged 1 to 15 who share cooking facilities with a cholera patient. Researchers will also check if this approach increases antibiotic-resistant bacteria, which could affect future treatment strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a single weight-based dose of the antibiotic azithromycin
What this could lead to
If effective, this could offer a simple way to protect children living with a cholera patient from getting sick, potentially saving lives in outbreak settings.
What could go wrong
This is a phase 2 trial, so results are preliminary. The drug may not prevent infection, and the study also examines whether it increases antibiotic-resistant bacteria, a potential downside.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

2,475 people

The number who actually took part.

Started

Oct 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 15 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cholera prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholera

Contacts and locations

Locations

  • icddr,b Dhaka hospital

    Dhaka, Bangladesh

More trials for these conditions

Other studies related to the condition(s) this trial covers.