CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66,228 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Weight or height-based oral azithromycin suspension administered every 6 months by direct observationAI-extracted
Key inclusion· 2
  • All children aged 1–60 months (up to but not including the 5th birthday)
  • Residing in communities eligible for MORDOR
Key exclusion· 2
  • Parental or guardian refusal
  • Village chief refusal (for village inclusion)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03338244
NCT03338244Phase 4Completed

Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

University of California, San Francisco·interventional·Posted Nov 9, 2017·Updated Aug 11, 2022

In Brief

A Phase 4 clinical trial evaluating Azithromycin and Placebo for Childhood Mortality. Completed, enrolled 66,228 participants across 2 sites in 2 countries.

Detailed 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 and fifth year of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNiger, United States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartOct 20, 2017
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.6 years ago

Interventions

Azithromycindrug

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months

Placebodrug

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months