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Mortality Reduction After Oral Azithromycin: Mortality Study (MORDOR)

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ClinicalTrials.gov Identifier: NCT02047981
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Johns Hopkins University
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality. We propose a single multi-site (multi-country), cluster-randomized trial comparing communities randomized to oral azithromycin with those randomized to placebo. We hypothesize that mass azithromycin treatments will reduce childhood mortality.

Condition or disease Intervention/treatment Phase
Childhood Mortality Drug: Azithromycin Drug: Placebo Phase 4

Detailed Description:

We will assess childhood mortality over two years, comparing communities where children aged 1-60 months receive biannual oral azithromycin ("Azithromycin" arm), to communities where the children receive biannual oral placebo ("Control" arm).

This is a cluster-randomized trial; at each site, communities within a contiguous area of 300,000 to 600,000 individuals will be randomized to azithromycin or placebo using simple random sampling.

Specific Aims

Specific Aim 1: To test the hypothesis that mass distributions of oral azithromycin targeted to 1-60 month old children reduces childhood mortality, in a cluster-randomized trial

Specific Aim 2: To assess the cost-effectiveness of mass azithromycin in reducing childhood mortality


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial
Study Start Date : December 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Biannual mass oral azithromycin

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years

Drug: Azithromycin
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years
Other Name: Zithromax

Placebo Comparator: Biannual mass oral placebo

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

Drug: Placebo
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years




Primary Outcome Measures :
  1. All-cause Mortality Rate in children aged 1-60 months [ Time Frame: 24 Months ]
    This is a single multi-site trial, with each country as a secondary analysis. Also, an interim analysis of efficacy and futility will be conducted according to a pre-specified plan in the Statistical Analysis Plan.


Secondary Outcome Measures :
  1. Cause-specific Mortality Rate in children aged 1-60 months, as assessed from verbal autopsy [ Time Frame: 24 Months ]
  2. Cost-effectiveness of mass azithromycin administration, per averted childhood death [ Time Frame: 24 months ]
  3. All-cause and cause-specific health clinic visits in 1-60 month-old children [ Time Frame: 24 months ]


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Ages Eligible for Study:   1 Month to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Communities

  • The community location in target district.
  • The community leader consents to participation in the trial
  • The community's estimated population is between 200-2,000 people.
  • The community is not in an urban area.

Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census.

Exclusion Criteria:

Individuals

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047981


Locations
United States, California
UCSF Proctor Foundation
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Malawi
College of Medicine at the University of Malawi, Blantyre
Blantyre, Malawi
Niger
The Carter Center, Niger
Niamey, Niger
Tanzania
Kongwa Trachoma Project
Kongwa, Tanzania
United Kingdom
London School of Hygiene & Tropical Medicine
London, United Kingdom
Sponsors and Collaborators
University of California, San Francisco
Bill and Melinda Gates Foundation
Johns Hopkins University
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Tom M Lietman, MD University of California, San Francisco
Study Director: Catherine A Cook, MPH University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02047981     History of Changes
Other Study ID Numbers: OPP1032340-A
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, San Francisco:
Childhood mortality
Azithromycin
Mass treatment
Infection
Verbal Autopsy