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Completed

NCT Number: NCT02047981

Mortality Reduction After Oral Azithromycin: Mortality Study

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.

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Key information

Conditions

Childhood Mortality Infections

Age range

1 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

College of Medicine at the University of Malawi, Blantyre, Blantyre, Malawi

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Azithromycin

Drug

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 names: Zithromax

Placebo

Drug

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.

Primary outcomes

  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.

  2. 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.

Secondary outcomes

  1. Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)

    Time frame: 24 Months

    Deaths were assessed via biannual population census. A pre-specified outcome was cause of death, assessed by verbal autopsy.

  2. Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death

    Time frame: 24 months

    Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death during the 24 month phase

  3. All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children

    Time frame: 24 months

    We recorded clinic visits one year prior the study and during the first year of the study and collected outcomes of these visit.

  4. Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)

    Time frame: 24 Months

    At 6-monthly intervals a census of the communities was conducted, and for child deaths a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. Mortality due to pneumonia or diarrhea by age group and arm are shown in the outcome measure data table below.

  5. Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)

    Time frame: 24 Months

    Cause-specific mortality by intention-to-treat for the four main inferred causes of death in the study area.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Johns Hopkins University
  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial

Acronym: MORDORIMort

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2014
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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