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

In the event that MORDOR (NCT02047981) established the efficacy of oral azithromycin in preventing mortality in 1-59 month children, the contingency study was to treat both arms in Niger with oral azithromycin (unmasked) for two more years in Niger only.

Details

Establish the effects of longer-term biannual mass azithromycin distribution.

Establish the efficacy of 3-4 years of mass azithromycin on child mortality compared to 1-2 years, to address loss (or augmentation) of efficacy with increasing years of distribution. For example, initial efficacy may be mitigated by increasing antibiotic resistance.

The primary outcome will be all-cause mortality in children aged 1-59 months, as determined by biannual census. A determination will be made whether there is an increase in mortality in communities randomized to stop versus continue mass azithromycin distributions both as compared to historical mortality in the placebo arm of MORDOR I and between randomization arms at 48 months.

Keywords

Childhood Mortality Mass treatment Azithromycin Infection Biannual mass oral azithromycin: 2 years Biannual mass oral azithromycin: 1 year

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 Foundation in progress, not accepting new patients
    San Francisco California 94143-0944 United States
  • The Carter Center accepting new patients
    Niamey Niger

Details

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