Clinical trial NCT02047981: Mortality Reduction After Oral Azithromycin: Mortality Study
Official title: Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Childhood Mortality
Keywords: Childhood mortality
Azithromycin
Mass treatment
Infection
Verbal Autopsy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Johns Hopkins University
name: London School of Hygiene and Tropical Medicine
First posted: 2014-01-29
Enrollment: 190238
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: All-cause Mortality Rate in Children Aged 1-60 Months
timeFrame: 24 Months
measure: All-cause Mortality Rate in Children Aged 1-60 Months
timeFrame: 36 months
Secondary outcomes:
measure: Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
timeFrame: 24 Months
measure: Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death
timeFrame: 24 months
measure: All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children
timeFrame: 24 months
measure: Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
timeFrame: 24 Months
measure: Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
timeFrame: 24 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Proctor Foundation
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Blantyre
country: Malawi
facility: College of Medicine at the University of Malawi, Blantyre
city: Niamey
country: Niger
facility: The Carter Center, Niger
city: Kongwa
country: Tanzania
facility: Kongwa Trachoma Project
city: London
country: United Kingdom
facility: London School of Hygiene & Tropical Medicine
Study officials:
affiliation: University of California, San Francisco
name: Tom M Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elodie J Lebas, RN
role: STUDY_DIRECTOR
References:
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