CholeraPhase 2NCT04326478
Single Dose Azithromycin to Prevent Cholera in Children
A Phase 2 study testing Azithromycin in people with Cholera, run by Massachusetts General Hospital at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,475 participants
- Where
- 1 siteBangladesh
- Study dates
- 31 Oct 2021to 31 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azithromycin Prophylaxis in Child Contacts of Cholera Patients: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cholera
- Being tested
- Azithromycin, Placebo
- Keywords
- Cholera, Child Health
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
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.
PlaceboBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start31 Oct 2021
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CholeraStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jason B. Harris, MD, Massachusetts General Hospital
- Investigators
- Jason B Harris, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326478
- Sponsor's protocol ID
- 2020P000457
- Other IDs
- R01HD102540
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2020
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Prophylaxis in Child Contacts of Cholera Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04326478
- Acronym / sponsor ID
- 2020P000457
- Conditions
- Cholera
- Keywords
- Cholera, Child Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,475 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Group | Experimental | Drug: AzithromycinEnrolled 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. |
| Non-antibiotic Placebo Group | Placebo comparator | Biological: PlaceboEnrolled 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. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinEnrolled 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. | Drug | Azithromycin Group |
| PlaceboEnrolled 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. | Biological | Non-antibiotic Placebo Group |
Primary outcome
Rate of V. Cholerae Infection in Household Contacts of Cholera Index Cases
Time frame: 1 week
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason B Harris, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin in people with Cholera, run by Massachusetts General Hospital at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of V. Cholerae Infection in Household Contacts of Cholera Index Cases (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.