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Mortality Reduction After Oral Azithromycin: Mortality Study (MORDORIMort)

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ClinicalTrials.gov Identifier: NCT02047981
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : December 13, 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

Tracking Information
First Submitted Date  ICMJE January 24, 2014
First Posted Date  ICMJE January 29, 2014
Last Update Posted Date December 13, 2018
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • 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.
  • All-cause Mortality Rate in children aged 1-60 months [ Time Frame: 36 months ]
    This was a pre-specified contingency study in Niger only in which all communities were treated with mass azithromycin during the third year of the study following the primary 24-month endpoint.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2014)
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 SAP.
Change History Complete list of historical versions of study NCT02047981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2014)
  • Cause-specific Mortality Rate in children aged 1-60 months, as assessed from verbal autopsy [ Time Frame: 24 Months ]
  • Cost-effectiveness of mass azithromycin administration, per averted childhood death [ Time Frame: 24 months ]
  • All-cause and cause-specific health clinic visits in 1-60 month-old children [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mortality Reduction After Oral Azithromycin: Mortality Study
Official Title  ICMJE Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial
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.
Detailed Description

We will assess childhood mortality over three years, comparing communities where children aged 1-60 months receive biannual oral azithromycin ("Azithromycin" arm) for two years, to communities where the children receive biannual oral placebo ("Control" arm) for two years. During the third year at the Niger site only, everyone will receive azithromycin.

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.

Niger contingency study: In the event that mass distributions of oral azithromycin are proven to reduce mortality in 1-60 month-old children, then we will treat all communities in Niger with mass azithromycin distributions to test whether the intervention continues to reduce childhood mortality after the initial 2 years of mass treatments.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Childhood Mortality
Intervention  ICMJE
  • 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. In Niger during year 3, all communities will be offered azithroymcin.
    Other Name: Zithromax
  • 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. In Niger during year 3, all communities will be offered azithroymcin.
Study Arms  ICMJE
  • 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.

    In Niger during year 3, all communities will be offered azithroymcin.

    Intervention: Drug: Azithromycin
  • 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

    In Niger during year 3, all communities will be offered azithroymcin.

    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2014)
227000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 60 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi,   Niger,   Tanzania,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02047981
Other Study ID Numbers  ICMJE OPP1032340-A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Johns Hopkins University
  • London School of Hygiene and Tropical Medicine
Investigators  ICMJE
Principal Investigator: Tom M Lietman, MD University of California, San Francisco
Study Director: Catherine A Cook, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP