Summary

Eligibility
for people ages 1 month and up (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
by Kieran O'BrienTom Lietman, MD
Headshot of Tom Lietman
Tom Lietman

Description

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.

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)

Details

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.

Keywords

Resistance Bacterial Morality Child Health Implementation Azithromycin Azithromycin for Oral Suspension Programmatic azithro 1-11

Eligibility

For people ages 1 month and up

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

Lead Scientists at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05288023
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 250000 study participants
Last Updated