NCT03338244

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66,228

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2017

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

July 1, 2022

Enrollment Period

2.8 years

First QC Date

November 7, 2017

Results QC Date

March 23, 2022

Last Update Submit

July 15, 2022

Conditions

Childhood Mortality

Keywords

Childhood mortalityMass treatmentAzithromycinInfection

Outcome Measures

Primary Outcomes (3)

  • 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

  • Macrolide Resistance in Children Aged 1-60 Months

    as measured by nasopharyngeal swabs

    18 months

  • 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 Outcomes (2)

  • Microbial Composition of Stool

    18 months

  • Campylobacter and Other Pathogenic Organisms in Stool

    18 months

Study Arms (2)

Azithro

ACTIVE COMPARATOR

Communities will receive four rounds of biannual mass azithromycin.

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Communities will receive four rounds of biannual mass placebo.

Drug: Placebo

Interventions

AzithromycinDRUG

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

Also known as: Zithromax
Azithro
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age1 Month - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSF Proctor Foundation

San Francisco, California, 94143-0944, United States

Location

The Carter Center

Niamey, Niger

Location

MeSH Terms

Conditions

Infections

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Thomas Lietman
Organization
UC San Francisco - Proctor Foundation
tom.lietman@ucsf.edu
(415) 476-1442

Study Officials

  • Tom M Lietman, MD

    UCSF Proctor Foundation

    PRINCIPAL INVESTIGATOR

  • Elodie Lebas, RN

    UCSF Proctor Foundation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

October 20, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 11, 2022

Results First Posted

August 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)NI(1)