Trial Outcomes & Findings for Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR) (NCT NCT05288023)
NCT ID: NCT05288023
Last Updated: 2025-03-28
Results Overview
Prevalence of genetic determinants of macrolide resistance including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus in nasopharyngeal swabs in children aged 1-59 months from population-based samples after 1 year of distribution
TERMINATED
PHASE4
169707 participants
2 years
2025-03-28
Participant Flow
Unit of analysis: Health Center
Participant milestones
| Measure |
Programmatic Azithro 1-11
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
Azithromycin for Oral Suspension: Azithromycin will be administered as a single dose in oral suspension form for children (up to the maximum adult dose of 1g).
Dosage will be calculated by age for children aged 1-5 months. For children 6-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.
|
no Intervention
No additional intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
135754 110
|
33953 56
|
|
Overall Study
COMPLETED
|
135754 110
|
33953 56
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex was not recorded
Baseline characteristics by cohort
| Measure |
Programmatic Azithro 1-11
n=135 Participants
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
Azithromycin for Oral Suspension: Azithromycin will be administered as a single dose in oral suspension form for children (up to the maximum adult dose of 1g).
Dosage will be calculated by age for children aged 1-5 months. For children 6-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.
|
No Intervention
n=33 Participants
No additional intervention.
|
Total
n=169707 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
135,754 Participants
n=135 Participants
|
33,953 Participants
n=33 Participants
|
169707 Participants
n=169707 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=135 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=169707 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=135 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=169707 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Sex was not recorded
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Sex was not recorded
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Niger
|
135,754 Participants
n=135 Participants
|
33,953 Participants
n=33 Participants
|
169707 Participants
n=169707 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The study stopped prior to the collection of outcome measures.
Prevalence of genetic determinants of macrolide resistance including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus in nasopharyngeal swabs in children aged 1-59 months from population-based samples after 1 year of distribution
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 yearsPopulation: The study stopped prior to the collection of outcome measures.
Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old from population-based samples, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study stopped prior to the collection of outcome measures.
Prevalence of resistance to macrolides including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus from nasopharyngeal swabs in children 1-59 months old.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study stopped prior to the collection of outcome measures.
Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study stopped prior to the collection of outcome measures.
Number of all-cause clinic visits per month for children aged 1-59 months over 1 year
Outcome measures
Outcome data not reported
Adverse Events
Programmatic Azithro 1-11
No Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kieran O'Brien
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place