Clinical trial NCT03338244: Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
Official title: Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Childhood Mortality
Keywords: Childhood mortality
Mass treatment
Azithromycin
Infection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: The Carter Center
name: Bill and Melinda Gates Foundation
First posted: 2017-11-09
Enrollment: 66228
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: All-cause Mortality Rate in Children Aged 1-60 Months
timeFrame: 24 months
measure: Macrolide Resistance in Children Aged 1-60 Months
timeFrame: 18 months
measure: Normalized Macrolide Resistance in Children Aged 1-60 Months
timeFrame: 18 months
Secondary outcomes:
measure: Microbial Composition of Stool
timeFrame: 18 months
measure: Campylobacter and Other Pathogenic Organisms in Stool
timeFrame: 18 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Proctor Foundation
state: California
city: Niamey
country: Niger
facility: The Carter Center
Study officials:
affiliation: UCSF Proctor Foundation
name: Tom M Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Proctor Foundation
name: Elodie Lebas, RN
role: STUDY_DIRECTOR
References: