Trial Outcomes & Findings for Azithromycin for Child Survival in Niger: Mortality and Resistance Trial (NCT NCT04224987)
NCT ID: NCT04224987
Last Updated: 2026-08-06
Results Overview
Mortality rate (deaths per 1,000 person-years at risk) among children 1-59 months of age, comparing the azithro 1-59 and placebo arms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
864493 participants
Primary outcome timeframe
from 6 months up to 2.5 years
Results posted on
2026-08-06
Participant Flow
Please note number of participants in participant flow, baseline characteristics, and analyzed population will differ. A participant is included in the participant flow if they participated in the study in at least one round. However participants are only included in baseline collections if they participated in the first data collection for that community. Participants are only included in analyzed populations if they participated in at least two rounds of data collection.
Unit of analysis: Communities
Participant milestones
| Measure |
Azithro 1-11
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Overall Study
STARTED
|
245227 751
|
334446 1229
|
284820 929
|
|
Overall Study
COMPLETED
|
245227 751
|
334446 1229
|
284820 929
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azithromycin for Child Survival in Niger: Mortality and Resistance Trial
Baseline characteristics by cohort
| Measure |
Azithro 1-11
n=431 communities
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=463 communities
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=463 communities
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Total
n=1357 communities
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age in months categorical · 1-11 months
|
7569 Participants
n=20 Participants
|
8220 Participants
n=20 Participants
|
7981 Participants
n=40 Participants
|
23770 Participants
n=6 Participants
|
|
Age, Customized
Age in months categorical · 12-23 months
|
8452 Participants
n=20 Participants
|
8922 Participants
n=20 Participants
|
8773 Participants
n=40 Participants
|
26147 Participants
n=6 Participants
|
|
Age, Customized
Age in months categorical · 24-59 months
|
25043 Participants
n=20 Participants
|
27270 Participants
n=20 Participants
|
26948 Participants
n=40 Participants
|
79261 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
20605 Participants
n=20 Participants
|
22078 Participants
n=20 Participants
|
21582 Participants
n=40 Participants
|
64265 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
20459 Participants
n=20 Participants
|
22334 Participants
n=20 Participants
|
22120 Participants
n=40 Participants
|
64913 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 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
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41064 Participants
n=20 Participants
|
44412 Participants
n=20 Participants
|
43702 Participants
n=40 Participants
|
129178 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Niger
|
41064 participants
n=20 Participants
|
44412 participants
n=20 Participants
|
43702 participants
n=40 Participants
|
129178 participants
n=6 Participants
|
|
Children per community
|
95.28 children per community
STANDARD_DEVIATION 71.36 • n=20 Participants
|
95.92 children per community
STANDARD_DEVIATION 67.48 • n=20 Participants
|
94.39 children per community
STANDARD_DEVIATION 61.65 • n=40 Participants
|
95.19 children per community
STANDARD_DEVIATION 66.79 • n=6 Participants
|
PRIMARY outcome
Timeframe: from 6 months up to 2.5 yearsMortality rate (deaths per 1,000 person-years at risk) among children 1-59 months of age, comparing the azithro 1-59 and placebo arms.
Outcome measures
| Measure |
Azithro 1-11
n=104 Participants
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=153 Participants
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=124 Participants
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
All-cause Mortality (1-59 Months Old)
|
13.8 deaths per 1,000 person-years
Interval 12.9 to 14.8
|
11.9 deaths per 1,000 person-years
Interval 11.3 to 12.6
|
13.9 deaths per 1,000 person-years
Interval 13.0 to 14.8
|
PRIMARY outcome
Timeframe: from 6 months up to 2.5 yearsMortality rate (deaths per 1,000 person-years at risk) among children 1-11 months of age, comparing the azithro 1-11 and placebo arms.
Outcome measures
| Measure |
Azithro 1-11
n=38 Participants
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=38 Participants
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=32 Participants
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
All-cause Mortality (1-11 Months Old)
|
22.3 deaths per 1,000 person years
Interval 10.0 to 24.7
|
18.5 deaths per 1,000 person years
Interval 16.7 to 20.4
|
23.9 deaths per 1,000 person years
Interval 21.6 to 26.2
|
PRIMARY outcome
Timeframe: from 6 months up to 2.5 yearsMortality rate (deaths per 1,000 person-years at risk) among children 12-59 months of age with rates compared between azithro 1-11 and azithro 1-59 communities.
Outcome measures
| Measure |
Azithro 1-11
n=65 Participants
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=115 Participants
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=92 Participants
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
All-cause Mortality (12-59 Months Old)
|
12.2 deaths per 1,000 person-years
Interval 11.3 to 13.1
|
10.7 deaths per 1,000 person-years
Interval 10.0 to 11.4
|
12.0 deaths per 1,000 person-years
Interval 11.2 to 13.0
|
PRIMARY outcome
Timeframe: After 4 distributions (approximately 24 months)Population: Children aged 1-59 months with post-treatment nasopharyngeal swabs that were culture-positive for pneumococcus and included in macrolide resistance testing.
Prevalence of macrolide resistance among pneumococcus-positive nasopharyngeal swabs collected from children aged 1-59 months after 4 distributions. Resistance was assessed among culture-positive pneumococcal isolates from nasopharyngeal swabs.
Outcome measures
| Measure |
Azithro 1-11
n=128 pneumococcus-positive nasopharyngeal sam
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=130 pneumococcus-positive nasopharyngeal sam
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=127 pneumococcus-positive nasopharyngeal sam
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)
|
128 macrolide-resistant pneumococcal isolate
|
130 macrolide-resistant pneumococcal isolate
|
127 macrolide-resistant pneumococcal isolate
|
PRIMARY outcome
Timeframe: After 4 distributions (approximately 24 months)Population: Participants from the same village were pooled, resulting in one pooled rectal sample analyzed per village; 50 pooled village-level samples were analyzed per arm.
Community-level load of macrolide antimicrobial resistance determinants in pooled rectal swabs collected from children aged 1-59 months after four biannual distributions. Rectal swabs from each community were pooled and analyzed using metagenomic DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts.
Outcome measures
| Measure |
Azithro 1-11
n=50 villages / pooled village samples
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=50 villages / pooled village samples
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=50 villages / pooled village samples
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)
|
130.70 Matched resistance reads per million non
Standard Deviation 34.31
|
415.59 Matched resistance reads per million non
Standard Deviation 31.36
|
125.77 Matched resistance reads per million non
Standard Deviation 30.70
|
SECONDARY outcome
Timeframe: After 4 distributions (approximatively 24 month after first distribution)Population: Children aged 1-11 months who were eligible for treatment and contributed at least one census interval with a recorded weight and a valid World Health Organization weight-for-age z-score between -6 and 5. Children with missing weight or implausible weight-for-age z-score values were excluded.
All-cause mortality incidence rate among children aged 1-11 months who had weight measured during at least one census round and had a valid weight-for-age z-score calculated using the World Health Organization Child Growth Standards. Nutritional status was assessed at the beginning of each census interval. This measure reports the overall mortality rate for this analysis population by randomized treatment arm and is not stratified by weight-for-age z-score subgroup. Mortality rates are reported as deaths per 1,000 person-years.
Outcome measures
| Measure |
Azithro 1-11
n=27842 Participants
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=37943 Participants
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=31781 Participants
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months
|
22.5 deaths per 1,000 person-years
Interval 20.0 to 25.2
|
18.1 deaths per 1,000 person-years
Interval 15.9 to 20.1
|
24 deaths per 1,000 person-years
Interval 21.4 to 26.6
|
SECONDARY outcome
Timeframe: After 4 distributions (approximatively 24 month after first distribution)Population: Guardians of children eligible for treatment from communities included in AMR spillover monitoring who provided nasopharyngeal swabs after approximately 24 months of study intervention. Samples were pooled by community, resulting in one pooled community-level nasopharyngeal sample per analyzed community.
Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from guardians of children eligible for treatment after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.
Outcome measures
| Measure |
Azithro 1-11
n=50 pooled community-level nasopharyngeal sa
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=50 pooled community-level nasopharyngeal sa
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=50 pooled community-level nasopharyngeal sa
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians
|
1.85 Matched resistance reads per million non
Standard Deviation 6.94
|
5.55 Matched resistance reads per million non
Standard Deviation 13.71
|
5.66 Matched resistance reads per million non
Standard Deviation 18.71
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis included program implementation activities and doses delivered during the cost substudy period. Costs were analyzed at the overall program level and were not stratified by randomized treatment arm because delivery costs were shared across arms and varied primarily by coverage.
Program cost per dose delivered was estimated using routine administrative data and micro-costing activities. Costs were calculated per dose delivered and were not stratified by randomized treatment arm.
Outcome measures
| Measure |
Azithro 1-11
n=3932586 Participants
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Program Costs Per Dose Delivered
|
1.59 US dollars per dose delivered
|
—
|
—
|
SECONDARY outcome
Timeframe: After 4 distributions, approximately 24 monthsPopulation: Children aged 7-12 years from communities included in AMR spillover monitoring who provided nasopharyngeal swabs after approximately 24 months of study intervention. Samples were pooled by community, resulting in one pooled community-level nasopharyngeal sample per analyzed community.
Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from children aged 7-12 years after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.
Outcome measures
| Measure |
Azithro 1-11
n=50 pooled community-level nasopharyngeal sa
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=50 pooled community-level nasopharyngeal sa
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=50 pooled community-level nasopharyngeal sa
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years
|
0.86 Matched resistance reads per million non
Standard Deviation 3.27
|
4.45 Matched resistance reads per million non
Standard Deviation 11.50
|
0.25 Matched resistance reads per million non
Standard Deviation 0.87
|
Adverse Events
Azithro 1-11
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1666 deaths
Azithro 1-59
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1914 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1923 deaths
Serious adverse events
| Measure |
Azithro 1-11
n=104374 participants at risk
Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Azithro 1-59
n=153626 participants at risk
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Azithromycin: Azithromycin will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight or age-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
Placebo
n=124617 participants at risk
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Placebo: Placebo will be administered as a directly observed dose in oral suspension form for children:
1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
2. For children 1-11 months of age, weight-based dosing will be used
3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program
|
|---|---|---|---|
|
General disorders
hospitalization for malaria
|
0.00%
0/104374 • 28 days
|
0.00%
0/153626 • 28 days
|
0.00%
2/124617 • Number of events 2 • 28 days
|
|
General disorders
Malaria, fever, diarrhea, vomiting
|
0.00%
1/104374 • Number of events 1 • 28 days
|
0.00%
0/153626 • 28 days
|
0.00%
0/124617 • 28 days
|
|
Gastrointestinal disorders
hospitalization for vomiting, diarrhea, and fever
|
0.00%
0/104374 • 28 days
|
0.00%
0/153626 • 28 days
|
0.00%
1/124617 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
diarrhea, fever and vomiting
|
0.00%
0/104374 • 28 days
|
0.00%
1/153626 • Number of events 1 • 28 days
|
0.00%
0/124617 • 28 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place