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NCT02048007 · ClinicalTrials.gov registry record · Phase 4

Mortality Reduction After Oral Azithromycin: Morbidity Study

A Phase 4 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
72,000
Enrollment target

NCT02048007: Completed Phase 4 study, sponsored by University of California, San Francisco.

NCT02048007 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 72,000 participants, above the 511-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13990% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02048007, a Phase 4 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
72,000 participants
Enrollment target

Study Summary

The long-term goal of this study is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and increasing growth, and for the potential selection of antibiotic resistance. The investigators propose a set of 3 cluster-randomized trials in Malawi, Niger, and Tanzania comparing communities randomized to oral azithromycin with those randomized to placebo. To assess the generalizability of the intervention, investigators will monitor for antibiotic resistance, which could potentially limit adoption of mass antibiotic treatments. The investigators will also assess several measures of infectious diseases. The investigators hypothesize that mass azithromycin treatments will reduce childhood morbidity and will be accompanied by an acceptable level of antibiotic resistance.

Primary Outcome

MORDOR Malawi, Tanzania and Niger. Please note: Each outcome will be analyzed separately for each study site.

Interventions

  • DRUG Placebo
  • DRUG Azithromycin

Trial Details

FieldValue
Enrollment Target 72,000 participants
Start Date 2014-11
Est. Completion 2020-08-27
Phase Phase 4

What the finished NCT02048007 record still lists

NCT02048007 is an interventional study that assigns participants to a tested intervention. Its 72,000 participants enrollment target places it among the larger protocols in the corpus, above the 511-participant average among 9,235 other Phase 4 trials with a reported enrollment target (13990% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02048007 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02048007 about?

NCT02048007 is a clinical study titled "Mortality Reduction After Oral Azithromycin: Morbidity Study". The long-term goal of this study is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and increasing growth, and for the potential selection of antibiotic resistance. The investigators propose a set of 3 cluster-randomized trials in...

What is the current status of trial NCT02048007?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 72,000 participants. The study started on 2014-11. Estimated completion is 2020-08-27.

What interventions are being tested in trial NCT02048007?

The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG).

Who is sponsoring clinical trial NCT02048007?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02048007's enrollment target sits among peer trials

72,000 4th of 2000 higher than 1,997 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02048007, the US trial registry maintained by the National Library of Medicine. NCT02048007 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.