Trial Outcomes & Findings for Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children (NCT NCT02414399)
NCT ID: NCT02414399
Last Updated: 2023-12-04
Results Overview
Incidence rate of a composite outcome of mortality and hospital readmission during the 6 month post-discharge (follow-up) period.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
1400 participants
Primary outcome timeframe
6 months
Results posted on
2023-12-04
Participant Flow
Two participants were withdrawn due to ineligibility (1 in the azithromycin arm and 1 in the placebo arm) therefore results are presented among 1398 instead of 1400.
Participant milestones
| Measure |
Azithromycin (n=702)
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Azithromycin: oral administration of Azithromycin
|
Placebo (n=696)
5 days of taste/appearance/bottle-matched placebo
Placebo: 5 days of taste/appearance/bottle-matched inactive substance
|
|---|---|---|
|
Overall Study
STARTED
|
702
|
696
|
|
Overall Study
COMPLETED
|
702
|
696
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Baseline characteristics by cohort
| Measure |
Azithromycin
n=702 Participants
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Azithromycin: oral administration of Azithromycin
|
Placebo
n=696 Participants
5 days of taste/appearance/bottle-matched placebo
Placebo: 5 days of taste/appearance/bottle-matched inactive substance
|
Total
n=1398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18 months
n=93 Participants
|
18 months
n=4 Participants
|
18 months
n=27 Participants
|
|
Sex: Female, Male
Female
|
276 Participants
n=93 Participants
|
294 Participants
n=4 Participants
|
570 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
426 Participants
n=93 Participants
|
402 Participants
n=4 Participants
|
828 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
702 Participants
n=93 Participants
|
696 Participants
n=4 Participants
|
1398 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
702 Participants
n=93 Participants
|
696 Participants
n=4 Participants
|
1398 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Kenya
|
702 participants
n=93 Participants
|
696 participants
n=4 Participants
|
1398 participants
n=27 Participants
|
|
Recruiting hospital
Kisii Teaching & Referral Hospital
|
412 Participants
n=93 Participants
|
410 Participants
n=4 Participants
|
822 Participants
n=27 Participants
|
|
Recruiting hospital
Homa Bay County Referral Hospital
|
259 Participants
n=93 Participants
|
262 Participants
n=4 Participants
|
521 Participants
n=27 Participants
|
|
Recruiting hospital
Kendu Adventist Hospital
|
20 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Recruiting hospital
St Paul Mission Hospital
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsIncidence rate of a composite outcome of mortality and hospital readmission during the 6 month post-discharge (follow-up) period.
Outcome measures
| Measure |
Azithromycin (n=702)
n=702 Participants
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Azithromycin: oral administration of Azithromycin
|
Placebo (n=696)
n=696 Participants
5 days of taste/appearance/bottle-matched placebo
Placebo: 5 days of taste/appearance/bottle-matched inactive substance
|
|---|---|---|
|
Re-hospitalization or Death
Death or rehospitalization
|
20.4 cases per 100 child years
|
22.5 cases per 100 child years
|
|
Re-hospitalization or Death
Death
|
4.7 cases per 100 child years
|
6.0 cases per 100 child years
|
|
Re-hospitalization or Death
Rehospitalization
|
18.8 cases per 100 child years
|
18.6 cases per 100 child years
|
SECONDARY outcome
Timeframe: 6 monthsMean change in length for age z-score (LAZ) between baseline and M3 or M6
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsThe number of children with diarrhea re-hospitalizations following randomization through follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPrevalence of enteric bacteria, viruses, and protozoa identified by qPCR at 3 months of follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPrevalence of Streptococcus pneumoniae from nasopharyngeal swabs collected at M3 and M6 follow-up timepoints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months (E.coli isolated at baseline, month 3, and month 6)Population: Children with E.coi isolated randomized to be in the antimicrobial resistance substudy
Among participants with E.coli isolated, # of participants with aizhtromycin resistance detected in E.coli form disc diffusion.
Outcome measures
| Measure |
Azithromycin (n=702)
n=219 Participants
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Azithromycin: oral administration of Azithromycin
|
Placebo (n=696)
n=187 Participants
5 days of taste/appearance/bottle-matched placebo
Placebo: 5 days of taste/appearance/bottle-matched inactive substance
|
|---|---|---|
|
Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin
M0
|
84 Participants
|
69 Participants
|
|
Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin
M3
|
52 Participants
|
30 Participants
|
|
Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin
M6
|
45 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Azithromycin (n=702)
Serious events: 52 serious events
Other events: 274 other events
Deaths: 15 deaths
Placebo (n=696)
Serious events: 54 serious events
Other events: 276 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Azithromycin (n=702)
n=702 participants at risk
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Azithromycin: oral administration of Azithromycin
|
Placebo (n=696)
n=696 participants at risk
5 days of taste/appearance/bottle-matched placebo
Placebo: 5 days of taste/appearance/bottle-matched inactive substance
|
|---|---|---|
|
Cardiac disorders
Grade 4 or 5 (cardiac disorders)
|
0.14%
1/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.14%
1/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Congenital, familial and genetic disorders
Grade 4 or 5 congenital disorders
|
0.00%
0/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.14%
1/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Gastrointestinal disorders
Grade 4 or 5 (gastrointestinal disorders)
|
0.28%
2/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.00%
0/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
General disorders
Grade 4 or 5 (general disorder)
|
0.14%
1/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.29%
2/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Infections and infestations
Grade 4 or 5 (infections)
|
6.1%
43/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
6.2%
43/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Injury, poisoning and procedural complications
Grade 4 or 5 (injury or poisoning)
|
0.14%
1/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.14%
1/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Renal and urinary disorders
Grade 4 or 5 (renal & urinary disorder)
|
0.28%
2/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.14%
1/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 or 5 (respiratory disorders)
|
0.43%
3/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.43%
3/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Blood and lymphatic system disorders
Grade 4 or 5 (blood and lymphatic system disorders)
|
1.9%
13/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
2.3%
16/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
Nervous system disorders
Grade 4 or 5 (nervous system disorders)
|
0.14%
1/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.72%
5/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
Other adverse events
| Measure |
Azithromycin (n=702)
n=702 participants at risk
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Azithromycin: oral administration of Azithromycin
|
Placebo (n=696)
n=696 participants at risk
5 days of taste/appearance/bottle-matched placebo
Placebo: 5 days of taste/appearance/bottle-matched inactive substance
|
|---|---|---|
|
General disorders
Grade 3 (not reported by system)
|
0.00%
0/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
0.00%
0/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
General disorders
Grade 2 (not reported by system)
|
27.5%
193/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
28.0%
195/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
|
General disorders
Grade 1 (not reported by system)
|
11.5%
81/702 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
11.6%
81/696 • 6 months
Adverse event grade (death=grade 5, life-threatening= grade 4, severe=grade 3, moderate=grade 2, mile=grade 1) is defined according to 2014 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place