Clinical trial NCT05288023: Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)
Official title: Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Resistance Bacterial
Morality
Child Health
Implementation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Ministry of Health, Niger
First posted: 2022-03-18
Enrollment: 169707
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial with response adaptive allocation
Primary purpose: TREATMENT

Brief summary: The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.

Detailed description: In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .

All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.

Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.

Eligibility criteria: Intervention

At the community-level, eligibility includes:

Inclusion Criteria:

* Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
* Distinguishable from neighboring communities
* Verbal consent of community leader(s)

Exclusion criteria:

* Inaccessible or unsafe for study team
* "Quartier" designation on national census

At the individual-level, eligibility includes:

Inclusion criteria:

* Age 1-11 months
* Primary residence in a study community
* Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

* Known allergy to macrolides

Population-based sample collections

At the community-level, eligibility includes:

Inclusion criteria:

* Location in study region
* Distinguishable from neighboring communities
* Verbal consent of community leader(s)

Exclusion criteria:

* Inaccessible or unsafe for study team
* Included in MORDOR trials
* Not randomly selected

At the individual-level, eligibility includes:

Inclusion criteria:

* Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
* Primary residence in a study community selected for sample collections
* Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

* Not on list of randomly selected participants from the census

Primary outcomes:
measure: Prevalence of Genetic Determinants of Macrolide Resistance From Population-based Samples
timeFrame: 2 years
measure: Load of Genetic Determinants of Macrolide Resistance From Population-based Samples
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of Genetic Determinants of Macrolide Resistance From Clinic-based Samples
timeFrame: 2 years
measure: Load of Genetic Determinants of Macrolide Resistance From Clinic-based Samples
timeFrame: 2 years
measure: Number of All-cause Clinic Visits
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Proctor foundation
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kieran O'Brien, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Tom Lietman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: WHO Guideline on Mass Drug Administration of Azithromycin to Children under Five Years of Age to Promote Child Survival [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK561641/
citation: Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.