Mortality Reduction After Oral Azithromycin Contingency: Mortality Study (MORDORIIMortY5)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Childhood Mortality

Treatments: Drug: Placebo; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03338244

OPP1032340-A

10-01036-Y4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66,228 patients

Sex: All

Ages: 1 to 60 months old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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: None (Open label)

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66,228 participants in 2 patient groups, including a placebo group

Azithro

Active Comparator group

Description:

Communities will receive four rounds of biannual mass azithromycin.

Treatment:

Drug: Azithromycin

Placebo

Placebo Comparator group

Description:

Communities will receive four rounds of biannual mass placebo.

Treatment:

Drug: Placebo