Trial Outcomes & Findings for Gut and Azithromycin Mechanisms in Infants and Children II (NCT NCT04315272)

NCT ID: NCT04315272

Last Updated: 2023-06-29

Results Overview

A rapid diagnostic test will be administered to all children to determine malaria status

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 449 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2023-06-29

Participant Flow

Participant milestones

Measure	Azithromycin 8 days to 59 months old were randomized to a single oral dose of azithromycin (20 mg/kg) Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.	Placebo A single dose of placebo will be administered to children between the ages of 8 days and 59 months old. Placebo: Oral suspension of placebo for azithromycin
Overall Study STARTED	221	228
Overall Study COMPLETED	220	227
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gut and Azithromycin Mechanisms in Infants and Children II

Baseline characteristics by cohort

Measure	Azithromycin n=221 Participants A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old. Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.	Placebo n=228 Participants A single dose of placebo will be administered to children between the ages of 8 days and 59 months old. Placebo: Placebo	Total n=449 Participants Total of all reporting groups
Age, Continuous	32 months n=5 Participants	32.5 months n=7 Participants	32 months n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	110 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	118 Participants n=7 Participants	232 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	221 Participants n=5 Participants	228 Participants n=7 Participants	449 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 Burkina Faso	221 Participants n=5 Participants	228 Participants n=7 Participants	449 Participants n=5 Participants
Mother's age, years	26 years n=5 Participants	27 years n=7 Participants	27 years n=5 Participants
Currently breastfeeding	64 Participants n=5 Participants	51 Participants n=7 Participants	115 Participants n=5 Participants
Mother is literate	92 Participants n=5 Participants	97 Participants n=7 Participants	189 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

A rapid diagnostic test will be administered to all children to determine malaria status

Outcome measures

Measure	Azithromycin n=220 Participants A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old. Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.	Placebo n=227 Participants A single dose of placebo will be administered to children between the ages of 8 days and 59 months old. Placebo: Placebo
Malaria Status	18 Participants	16 Participants

SECONDARY outcome

Timeframe: 2 weeks

Clinical malaria will be defined by a positive rapid diagnostic test and fever.

Outcome measures

Measure	Azithromycin n=220 Participants A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old. Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.	Placebo n=227 Participants A single dose of placebo will be administered to children between the ages of 8 days and 59 months old. Placebo: Placebo
Clinical Malaria	6 Participants	6 Participants

Adverse Events

Azithromycin

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Azithromycin n=220 participants at risk A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old. Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.	Placebo n=227 participants at risk A single dose of placebo will be administered to children between the ages of 8 days and 59 months old. Placebo: Placebo
General disorders Fever	3.6% 8/220 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.	8.4% 19/227 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
General disorders Abdominal pain	0.91% 2/220 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.	1.8% 4/227 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
Gastrointestinal disorders Diarrhea	5.0% 11/220 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.	7.9% 18/227 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
Gastrointestinal disorders Vomiting	2.7% 6/220 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.	6.2% 14/227 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
Gastrointestinal disorders Constipation	0.45% 1/220 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.	0.88% 2/227 • 14 days following azithromycin or placebo treatment We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.

Additional Information

Dr Catherine Oldenburg

UCSF FI Proctor Foundation

Phone: (415) 502-8843

Email: catherine.oldenburg@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place