Azithromycin for Child Survival in Niger II
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-59
SponsorUniversity of California, San Francisco
About this trial
Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Located in a region participating in the program
Designated as rural by local study team
Selected for participation in monitoring activities
Safe and accessible for study teams
Disqualifiers
Designated as urban by local study team
Inaccessible or unsafe for study team
Known allergy to macrolides
Trial design
Design model
Parallel
Treatments tested in this trial
Azithromycin for Oral Suspension
DrugAzithromycin will be administered as a single dose, in oral suspension form for children. The dose will be calculated by age or height depending on the child's age Both dosing cups and syringes will be used to administer treatment. For children too young to drink out of a dosing cup, a 1 ml or 5 ml syringe will be used, and the calculated dose will be rounded upwards to the nearest 0.2 ml.
Treatment groups
3,300,000 Participants
are divided into 3 treatment groupsGroup A: Continuous DistributionActive comparator 1 intervention
Group B: Delayed DistributionActive comparator 1 intervention
Group C: Stop DistributionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 2 years from the first treatment distribution, comparing the intervention and delayed arms
Time frame
2 years2
All-cause mortality
Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 4 years, comparing the continue and stop arms
Time frame
4 years3
Prevalence of resistance to macrolides - nasopharyngeal swabs
Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms
Time frame
2 years4
Prevalence of resistance to macrolides - nasopharyngeal swabs
Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms
Time frame
4 yearsSecondary outcomes
1
Number of clinic visits - infectious
All infectious clinic visits among children 1-59 months of age in the program catchment area during the distribution period as assessed through passive surveillance of CSI records
Time frame
2 years2
Number of clinic visits - infectious
All infectious clinic visits among children 1-59 months of age in the program catchment area during the distribution period as assessed through passive surveillance of CSI records
Time frame
4 years3
Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs
Prevalence of genetic determinants of resistance from nasopharyngeal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms
Time frame
2 years4
Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs
Prevalence of genetic determinants of resistance from nasopharyngeal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms
Time frame
4 yearsSponsors and contacts
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University of California, San Francisco
Lead sponsor
Centre de recherche et interventions en santé publique (CRISP)
Collaborator
Ministère de la Santé Publique du Niger
Collaborator
Le Programme National de Santé Oculaire
Collaborator
Centre de Recherche Médicale et Sanitaire
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov