Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Childhood Mortality Clinical Trial

— MORDORIIMortY5  

Official title:

Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338244
• Other study ID #: 10-01036-Y4
• Secondary ID: OPP1032340-A
• Status: Completed
• Phase: Phase 4
• Start date: October 20, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66228
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 60 Months

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Mortality

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Niger	The Carter Center	Niamey
United States	UCSF Proctor Foundation	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, The Carter Center

Countries where clinical trial is conducted

United States,  Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality Rate in Children Aged 1-60 Months	as measured by presence on census and absence on sequential census due to death	24 months
Primary	Macrolide Resistance in Children Aged 1-60 Months	as measured by nasopharyngeal swabs	18 months
Primary	Normalized Macrolide Resistance in Children Aged 1-60 Months	as measured by rectal swabs. Fraction of macrolide resistance from stool specimens in children 1-60 months (core). For Niger, this includes RNA, DNA, and TAC-card methods (a binary outcome at the individual level).	18 months
Secondary	Microbial Composition of Stool	as measured by Meta-genomic Deep Sequencing	18 months
Secondary	Campylobacter and Other Pathogenic Organisms in Stool	as measured by molecular techniques	18 months