Trial Outcomes & Findings for Single Dose Azithromycin to Prevent Cholera in Children (NCT NCT04326478)
NCT ID: NCT04326478
Last Updated: 2026-08-07
Results Overview
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.
COMPLETED
PHASE2
2475 participants
1 week
2026-08-07
Participant Flow
Participants were recruited from households of index patients with culture-confirmed cholera in Dhaka, Bangladesh. Eligible participants were household child contacts 1 to 15 years of age.
2,475 individuals provided informed consent and were considered enrolled in the study: 1,848 index patients with cholera and 627 eligible household contacts. The index patients were enrolled to identify eligible households and child contacts but were not assigned to an intervention and not included in the assessment of trial outcomes. The Participant Flow module therefore begins with the 627 child household contacts from 402 households who were assigned by household to azithromycin or placebo.
Unit of analysis: Households
Participant milestones
| Measure |
Azithromycin
Participants in households assigned to this group received a single oral dose of azithromycin according to the trial protocol.
|
Placebo
Participants in households assigned to this group received a single oral dose of placebo according to the trial protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
314 201
|
313 201
|
|
Overall Study
COMPLETED
|
314 201
|
313 201
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose Azithromycin to Prevent Cholera in Children
Baseline characteristics by cohort
| Measure |
Azithromycin
n=314 Participants
Participants in households assigned to this group received a single oral dose of azithromycin according to the trial protocol.
|
Placebo
n=313 Participants
Participants in households assigned to this group received a single oral dose of placebo according to the trial protocol.
|
Total
n=627 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
314 Participants
n=20 Participants
|
313 Participants
n=20 Participants
|
627 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=20 Participants
|
158 Participants
n=20 Participants
|
304 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=20 Participants
|
155 Participants
n=20 Participants
|
323 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
314 Participants
n=20 Participants
|
313 Participants
n=20 Participants
|
627 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Bangladesh
|
314 Participants
n=20 Participants
|
313 Participants
n=20 Participants
|
627 Participants
n=40 Participants
|
|
Participants Assigned an Intervention
|
314 Participants
n=20 Participants
|
313 Participants
n=20 Participants
|
627 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Only household contacts assigned to an intervention - not screened and index patients
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.
Outcome measures
| Measure |
Azithromycin
n=314 Participants
Participants in households assigned to this group received a single oral dose of azithromycin according to the trial protocol.
|
Placebo
n=313 Participants
Participants in households assigned to this group received a single oral dose of placebo according to the trial protocol.
|
|---|---|---|
|
Rate of V. Cholerae Infection in Household Contacts of Cholera Index Cases
Culture positive, ITT
|
27 Participants
|
67 Participants
|
|
Rate of V. Cholerae Infection in Household Contacts of Cholera Index Cases
Culture negative, ITT
|
287 Participants
|
246 Participants
|
Adverse Events
Azithromycin Group
Non-antibiotic Placebo Group
Serious adverse events
| Measure |
Azithromycin Group
n=314 participants at risk
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.
Azithromycin: 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.
|
Non-antibiotic Placebo Group
n=313 participants at risk
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.
Placebo: 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.
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
0.00%
0/314 • 6 months
No difference
|
0.32%
1/313 • Number of events 1 • 6 months
No difference
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place