Trial Outcomes & Findings for Azithromycin Reduction to Reach Elimination of Trachoma (NCT NCT04185402)
NCT ID: NCT04185402
Last Updated: 2026-03-25
Results Overview
Assessed by PCR
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3931 participants
Primary outcome timeframe
36 months
Results posted on
2026-03-25
Participant Flow
Communities (grappes) were randomized as the unit of allocation. Monitoring surveys for outcome assessment enrolled children residing in study communities; adults were not enrolled as study participants for outcome assessment.
Unit of analysis: Grappe (village)
Participant milestones
| Measure |
Azithromycin Continuation
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
Azithromycin: In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
|
Azithromycin Discontinuation
In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.
|
|---|---|---|
|
Baseline Survey
STARTED
|
1950 39
|
1981 40
|
|
Baseline Survey
COMPLETED
|
1950 39
|
1981 40
|
|
Baseline Survey
NOT COMPLETED
|
0 0
|
0 0
|
|
36 Months Survey
STARTED
|
2009 40
|
1990 40
|
|
36 Months Survey
COMPLETED
|
2009 40
|
1990 40
|
|
36 Months Survey
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azithromycin Reduction to Reach Elimination of Trachoma
Baseline characteristics by cohort
| Measure |
Azithromycin Continuation
n=1950 Participants
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
Azithromycin: In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
|
Azithromycin Discontinuation
n=1981 Participants
In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.
|
Total
n=3931 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1950 Participants
n=138 Participants
|
1981 Participants
n=62 Participants
|
3931 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Continuous
|
4.0 year
STANDARD_DEVIATION 2.6 • n=138 Participants
|
4.0 year
STANDARD_DEVIATION 2.5 • n=62 Participants
|
4.0 year
STANDARD_DEVIATION 2.6 • n=123 Participants
|
|
Sex: Female, Male
Female
|
958 Participants
n=138 Participants
|
966 Participants
n=62 Participants
|
1924 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
992 Participants
n=138 Participants
|
1015 Participants
n=62 Participants
|
2007 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1950 Participants
n=138 Participants
|
1981 Participants
n=62 Participants
|
3931 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Region of Enrollment
Niger
|
1950 participants
n=138 Participants
|
1981 participants
n=62 Participants
|
3931 participants
n=123 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow.
Assessed by PCR
Outcome measures
| Measure |
Azithromycin Continuation
n=1993 Participants
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
Azithromycin: In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
|
Azithromycin Discontinuation
n=1978 Participants
In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.
|
|---|---|---|
|
Ocular Chlamydia Measured in a Population-based Sample of 0-9 Year-old Children
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow.
Assessed by PCR
Outcome measures
| Measure |
Azithromycin Continuation
n=1993 Participants
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
Azithromycin: In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
|
Azithromycin Discontinuation
n=1978 Participants
In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.
|
|---|---|---|
|
Infectious Load of Chlamydia Among 0-9 Year-old Children Infected With Ocular Chlamydia
|
0 copies/mL
Standard Deviation 0
|
0 copies/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: This is a cluster-randomized trial wit cross-sectional data collection at baseline and endline. Participant Flow reflects counts of clusters and enrolled children, not the analytic dataset. The number analyzed includes all eligible individuals captured in the cross-sectional villages, which may exceed the number 'Started' in Participant Flow.
Assessed from conjunctival photography. Clinical photographs of the conjunctiva will be assessed by masked graders according to the grading scale described by the WHO Simplified Grading System.
Outcome measures
| Measure |
Azithromycin Continuation
n=1999 Participants
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
Azithromycin: In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
|
Azithromycin Discontinuation
n=1981 Participants
In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.
|
|---|---|---|
|
Conjunctival Inflammation
|
6 Participants
|
4 Participants
|
Adverse Events
Azithromycin Continuation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin Discontinuation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place