Mortality Reduction After Oral Azithromycin: Mortality Study

Childhood Mortality Clinical Trial

— MORDORIMort  

Official title:

Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047981
• Other study ID #: OPP1032340-A
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: September 2018

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190238
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 60 Months

Eligibility

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)

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
• 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.

Locations

Country	Name	City	State
Malawi	College of Medicine at the University of Malawi, Blantyre	Blantyre
Niger	The Carter Center, Niger	Niamey
Tanzania	Kongwa Trachoma Project	Kongwa
United Kingdom	London School of Hygiene & Tropical Medicine	London
United States	Johns Hopkins University	Baltimore	Maryland
United States	UCSF Proctor Foundation	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, Johns Hopkins University, London School of Hygiene and Tropical Medicine

Countries where clinical trial is conducted

United States,  Malawi,  Niger,  Tanzania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality Rate in Children Aged 1-60 Months	This is a single multi-site trial, with each country as a secondary analysis. Also, an interim analysis of efficacy and futility will be conducted according to a pre-specified plan in the Statistical Analysis Plan.	24 Months
Primary	All-cause Mortality Rate in Children Aged 1-60 Months	This was a pre-specified contingency study in Niger only in which all communities were treated with mass azithromycin during the third year of the study following the primary 24-month endpoint.	36 months
Secondary	Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)	Deaths were assessed via biannual population census. A pre-specified outcome was cause of death, assessed by verbal autopsy.	24 Months
Secondary	Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death	Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death during the 24 month phase	24 months
Secondary	All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children	We recorded clinic visits one year prior the study and during the first year of the study and collected outcomes of these visit.	24 months
Secondary	Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)	At 6-monthly intervals a census of the communities was conducted, and for child deaths a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. Mortality due to pneumonia or diarrhea by age group and arm are shown in the outcome measure data table below.	24 Months
Secondary	Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)	Cause-specific mortality by intention-to-treat for the four main inferred causes of death in the study area.	24 Months