Summary

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

Description

Summary

The trial, Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) (NCT02047981) demonstrated that biannual distribution of azithromycin to children 1-59 months old reduces child mortality. Targeting treatment to children 1-11 months old could reduce selection for resistance by limiting antibiotic distributions while maximizing the mortality benefit by targeting treatment to children at the highest mortality risk. Such a targeted intervention remains untested, however. The investigator's objective in this study is to determine the optimal age group to treat with biannual oral azithromycin distribution to reduce child mortality.

Official Title

Azithromycine Pour la Vie Des Enfants au Niger: Implémentation et Recherche Azithromycin for Child Survival in Niger: Implementation and Research

Details

Eligible communities in Niger will be randomized to one of three azithromycin distribution strategies: 1) biannual oral azithromycin to children 1-11 months old with biannual oral placebo to children 12-59 months old, 2) biannual oral azithromycin to children 1-59 months old, or 3) biannual oral placebo to children 1-59 months old.

Mortality will be monitored through biannual census data collection, which will be used to adaptively allocate treatment assignments, with the allocation updated at each treatment period and individual communities retaining their allocation for 4 distributions. Antimicrobial resistance will be monitored using cluster sampling of different groups of children and adults in the Dosso region. Additional data will be collected on implementation outcomes, including costs, reach and coverage, acceptability/adoption, and maintenance/sustainability.

Implementation will be phased in by region. Dosso will be enrolled in the first year, Maradi and Zinder in the second year, and secure areas of Tillabéri and Tahoua and in the third year.

Keywords

Mortality Resistance Bacterial Child, Only Mass Treatment Azithromycin Childhood Mortality Rate Antimicrobial Resistance Implementation and Cost Analysis Azithro 1-11 Azithro 1-59

Eligibility

For people ages 1 month and up

  1. Census and Treatment

At the community-level, eligibility includes:

Inclusion Criteria:

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

  • Population 250 to < 2,500 at the previous national census
  • Verbal consent of community leader(s)

Exclusion criteria:

• Location in Niamey, Agadez, or Diffa regions

  • Population < 250 or ≥ 2,500 at the previous census
  • Inaccessible or unsafe for study team

At the individual-level, eligibility includes:

Inclusion criteria:

• Age 1-59 months

  • Primary residence in a study community
  • Verbal consent of caregiver for study participation
  • Weight ≥ 3.0 kg

Exclusion criteria:

• Known allergy to macrolides

  1. Rectal Swab, or Stool, blood sample and nasopharyngeal (NP) Swab Collections

At the community-level, eligibility includes:

Inclusion Criteria:

• Location in Dosso

• Verbal consent of community leader(s)

Exclusion criteria:

• Location in region other than Dosso

• Inaccessible or unsafe for study team

At the individual-level, eligibility includes:

Inclusion Criteria:

• Age is 1-59 months or 7-12 years or individual is the mother of an eligible child

  • Primary residence in a study community selected for resistance sampling
  • Verbal consent of caregiver for study participation

Exclusion criteria:

• An individual is not on the list of randomly selected participants from the census

  1. Children presenting to hospitals with septicemia:

At the health center-level, eligibility includes:

Inclusion Criteria:

  • Hospital in Dosso
  • Verbal consent of community leader(s)

Exclusion Criteria:

• Not randomly selected for participation

At the individual-level, eligibility includes:

Inclusion Criteria

  • Age 1-59 months
  • Primary residence in a study community
  • Verbal consent of caregiver for study participation
  • Presents to one of the 4 hospitals in Dosso with symptoms of septicemia

Exclusion criteria:

• Does not meet criteria for a septicemia diagnosis

Lead Scientist at UCSF

  • Tom M Lietman, MD
    Professor, Proctor Foundation. Authored (or co-authored) 358 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04224987
Phase
Phase 4
Study Type
Interventional
Last Updated