Summary

for people ages 1 month to 60 months (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Tom M Lietman

Description

Summary

MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. All communities were subsequently treated with mass azithromycin for one year. The present trial re-randomized communities to azithromycin or placebo for the fourth year of the study.

Details

Pre-trial treatments: in the original MORDOR trial, communities were randomized to 4 rounds of biannual mass distributions of either azithromycin or placebo (i.e, the first two years of the trial). All communities were subsequently treated with 2 rounds of biannual mass azithromycin (i.e., the fifth and sixth rounds, during the third year of the trial).

Present trial design: The present trial enrolls all communities previously enrolled in the Niger site of MORDOR, and re-randomizes communities to biannual mass distributions of either azithromycin or placebo (i.e., the seventh and eighth rounds of mass drug administration since randomization for the original MORDOR trial, occurring in the fourth year since randomization). This results in four patterns of community-based treatment: four years of azithromycin (AAAA), three years of azithromycin followed by one year of placebo (AAAP), two years of placebo followed by two years of azithromycin (PPAA), and two years of placebo followed by one year of azithromycin and then one year of placebo (PPAP). The primary outcome will be all-cause mortality in children aged 1-59 months, as determined by biannual census. The mortality rate following re-randomization (i.e., the seventh and eighth rounds of mass drug administration) will be compared between the two re-randomized groups.

Keywords

Childhood MortalityMass treatmentAzithromycinInfectionAzithro

Eligibility

You can join if…

Open to people ages 1 month to 60 months

  • Communities- All communities eligible for MORDOR (NCT02047981)
  • Individuals-All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census

You CAN'T join if...

  • Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Locations

  • UCSF Proctor Foundationin progress, not accepting new patients
    San FranciscoCalifornia94143-0944United States
  • The Carter Centeraccepting new patients
    NiameyNiger

Lead Scientist

  • Tom M Lietman
    Authored (or co-authored) 241 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03338244
Phase
Phase 4
Study Type
Interventional
Last Updated