Trial Outcomes & Findings for Mortality Reduction After Oral Azithromycin Contingency: Mortality Study (NCT NCT03338244)

NCT ID: NCT03338244

Last Updated: 2022-08-11

Results Overview

as measured by presence on census and absence on sequential census due to death

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66228 participants

Primary outcome timeframe

24 months

Results posted on

2022-08-11

Participant Flow

Unit of analysis: village

Participant milestones

Participant milestones
Measure	Azithro Communities will receive four rounds of biannual mass azithromycin. 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 Communities will receive four rounds of biannual mass placebo. 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
Overall Study STARTED	33173 295	33055 297
Overall Study COMPLETED	25995 295	25568 297
Overall Study NOT COMPLETED	7178 0	7487 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithro n=33173 Participants Communities will receive four rounds of biannual mass azithromycin. 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 n=33055 Participants Communities will receive four rounds of biannual mass placebo. 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	Total n=66228 Participants Total of all reporting groups
Age, Categorical <=18 years	33173 Participants n=5 Participants	33055 Participants n=7 Participants	66228 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16052 Participants n=5 Participants	16084 Participants n=7 Participants	32136 Participants n=5 Participants
Sex: Female, Male Male	17121 Participants n=5 Participants	16971 Participants n=7 Participants	34092 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33173 Participants n=5 Participants	33055 Participants n=7 Participants	66228 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Niger	33173 participants n=5 Participants	33055 participants n=7 Participants	66228 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Number of participants at the start of MORDOR III

as measured by presence on census and absence on sequential census due to death

Outcome measures

Outcome measures
Measure	Azithro n=33173 Participants Communities will receive four rounds of biannual mass azithromycin. 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 n=33055 Participants Communities will receive four rounds of biannual mass placebo. 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
All-cause Mortality Rate in Children Aged 1-60 Months	24.8 deaths per 1000 person years Interval 23.1 to 26.5	26.7 deaths per 1000 person years Interval 24.5 to 28.5

PRIMARY outcome

Timeframe: 18 months

Population: We did collect nasopharyngeal swabs but pooling and DNA-seq that works with rectal samples was not sensitive enough for NP samples. So we have to wait for technology to catch up to be able to report these results.

as measured by nasopharyngeal swabs

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 18 months

Population: 1,004 children in total (557 from 15 placebo-treated communities and 447 from 14 azithromycin-treated communities).

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).

Outcome measures

Outcome measures
Measure	Azithro n=447 Participants Communities will receive four rounds of biannual mass azithromycin. 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 n=557 Participants Communities will receive four rounds of biannual mass placebo. 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
Normalized Macrolide Resistance in Children Aged 1-60 Months	79.85 reads per million (rM) Interval 44.31 to 124.14	15.79 reads per million (rM) Interval 5.72 to 27.39

SECONDARY outcome

Timeframe: 18 months

Population: Unfortunately, we didn't collect stool, so we won't be able to report this.

as measured by Meta-genomic Deep Sequencing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Unfortunately, we didn't collect stool, so we won't be able to report this.

as measured by molecular techniques

Outcome measures

Outcome data not reported

Adverse Events

Azithro

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1493 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1584 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Lietman

UC San Francisco - Proctor Foundation

Phone: (415) 476-1442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place