Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Mortality Trial and Resistance Trial)

Who is this study for? Infant patients with Antibiotic-Resistant Bacterial Infection
What treatments are being studied? Azithromycin
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested. The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on antimicrobial resistance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 4
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions

• Population 250 to 2,499*

• Distance > 5 km from district headquarters town

• Distinguishable from neighboring communities

• Verbal consent of community leader(s)

• Age 1-59 months

• Primary residence in a study community

• Verbal consent of caregiver/guardian for study participation

• Weight ≥ 3.0 kg (*no weight limits in communities using age-based dosing)

• Location in Dosso

• Distinguishable from neighboring communities

• Verbal consent of community leader(s)

• 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

Locations
Other Locations
Niger
Programme national de santé oculaire
Recruiting
Niamey
Contact Information
Primary
Elodie Lebas, RN
elodie.lebas@ucsf.edu
5104232245
Time Frame
Start Date: November 24, 2020
Estimated Completion Date: March 2026
Participants
Target number of participants: 1106050
Treatments
Active Comparator: 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
Active Comparator: Azithro 1-59
Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old
Placebo Comparator: Placebo
Biannual weight- or height-based dose of oral placebo to children 1-59 months old
Authors
Tom M Lietman, Kieran S O'Brien
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, Niger, Bill and Melinda Gates Foundation
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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