Mortality Reduction After Oral Azithromycin: Mortality Study (MORDORIMort)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Childhood Mortality

Treatments: Drug: Azithromycin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02047981

OPP1032340-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190,238 patients

Sex: All

Ages: 1 to 60 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190,238 participants in 2 patient groups, including a placebo group

Biannual mass oral azithromycin

Active Comparator group

Description:

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.

Treatment:

Drug: Azithromycin

Biannual mass oral placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo