Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2020-07-31

Brief Summary

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MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. All communities were subsequently treated with mass azithromycin for one year. The present trial re-randomized communities to azithromycin or placebo for the fourth and fifth year of the study.

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Detailed Description

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Pre-trial treatments: in the original MORDOR trial, communities were randomized to 4 rounds of biannual mass distributions of either azithromycin or placebo (i.e, the first two years of the trial). All communities were subsequently treated with 2 rounds of biannual mass azithromycin (i.e., the fifth and sixth rounds, during the third year of the trial).

Present trial design: The present trial enrolls all communities previously enrolled in the Niger site of MORDOR, and re-randomizes communities to biannual mass distributions of either azithromycin or placebo (i.e., the seventh, eighth, ninth and tenth rounds of mass drug administration since randomization for the original MORDOR trial, occurring in the fourth and fifth year since randomization). This results in four patterns of community-based treatment: four years of azithromycin (AAAAA), three years of azithromycin followed by one year of placebo (AAAPP), two years of placebo followed by two years of azithromycin (PPAAA), and two years of placebo followed by one year of azithromycin and then one year of placebo (PPAPP). The primary outcome will be all-cause mortality in children aged 1-59 months,as determined by biannual census. The mortality rate following re-randomization (i.e., the seventh, eighth, ninth and tenth rounds of mass drug administration) will be compared between the two re-randomized groups.

Conditions

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Childhood Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithro

Communities will receive four rounds of biannual mass azithromycin.

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type 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

Placebo

Communities will receive four rounds of biannual mass placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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Inclusion Criteria

* Communities- All communities eligible for MORDOR (NCT02047981)
* Individuals-All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census