Trial Outcomes & Findings for Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria (NCT NCT05473234)

NCT ID: NCT05473234

Last Updated: 2025-02-25

Results Overview

Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 310 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-02-25

Participant Flow

Participant milestones

Measure	Amoxicillin Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Overall Study STARTED	151	159
Overall Study 8 Weeks	96	120
Overall Study COMPLETED	42	58
Overall Study NOT COMPLETED	109	101

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

Baseline characteristics by cohort

Measure	Amoxicillin n=151 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=159 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.	Total n=310 Participants Total of all reporting groups
Age, Continuous	15.79 month STANDARD_DEVIATION 7.8 • n=5 Participants	16.52 month STANDARD_DEVIATION 8.7 • n=7 Participants	16.16 month STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	81 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	78 Participants n=7 Participants	153 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	151 Participants n=5 Participants	159 Participants n=7 Participants	310 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 Nigeria	151 participants n=5 Participants	159 participants n=7 Participants	310 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 96 children in Amoxicillin arm and 120 children in Azithromycin arm had anthropometry form collected between the 8 weeks window (42 to 70 days)

Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day

Outcome measures

Measure	Amoxicillin n=96 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=120 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Weight Gain at 8 Weeks	30.42 g/day Standard Deviation 17.11	27.75 g/day Standard Deviation 18.82

SECONDARY outcome

Timeframe: 8 weeks

Population: 96 children in Amoxicillin arm and 120 children in Azithromycin arm had anthropometry form collected between the 8 weeks window (42 to 70 days)

Nutritional recovery will be defined as a child having WHZ ≥ -2 on two consecutive visits and no acute complication or edema for the past 7 days AND / OR MUAC of ≥ 125mm on 2 consecutive visits and no acute complication or edema for the past 7 days.

Children will be considered recovered or not recovered using these criteria

Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards

A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ < -2 standard distributions below the median is defined as moderately wasted, while a WHZ < -3 standard distributions below the median is defined as severely wasted.

Outcome measures

Measure	Amoxicillin n=96 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=120 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Number of Participants With Nutritional Recovery at 8 Weeks	85 Participants	105 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days)

Weight will be measured at baseline and weekly follow up visits for 8 weeks, and at 12 weeks after admission to the program. Weight gain will be defined as grams per kilogram per day (g/day).

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Weight Gain Over 12 Weeks	22.67 g/day Standard Deviation 13.13	23.89 g/day Standard Deviation 11.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Time from enrollment to nutritional recovery will be calculated in days by subtracting the date of enrollment from the date of nutritional recovery.

Outcome measures

Measure	Amoxicillin n=133 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=150 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Time to Recovery	21.4 days Standard Deviation 19.2	22.4 days Standard Deviation 19.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Number of children with nonresponse will be documented if a child does not meet the criteria for nutritional recovery at 8 weeks after enrollment.

Outcome measures

Measure	Amoxicillin n=96 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=120 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Nonresponse at 8 Weeks	11 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days)

The occurrence, date, and reason for transfer from outpatient to inpatient treatment will be recorded.

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Number of Participants Who Transferred to Inpatient Care	3 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Vital status will be assessed at baseline and at weekly follow up visits for 8 weeks, and mortality will be defined as death during the study period. Date of death will be recorded.

Outcome measures

Measure	Amoxicillin n=96 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=120 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Mortality by 8 Weeks	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Vital status will be assessed at baseline, weekly follow up visits for 8 weeks, and at 12 weeks, and mortality will be defined as death during the study period. Date of death will be recorded.

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Mortality by 12 Weeks	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Number of participants with clinical sign of infection will be recorded At baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit, including care-giver reported experience of fever, diarrhea, vomiting, and respiratory infection/cough and clinical diagnoses made at by site personnel

Outcome measures

Measure	Amoxicillin n=32 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=50 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Clinical Signs of Infection	6 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days)

Height or length will be measured monthly (baseline and the 4-, 8-, and 12-week follow up visits) and height-for-age z-scores will be calculated.

Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards

A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A HAZ < -2 standard distributions below the median is defined as stunted, while a HAZ < -3 standard distributions below the median is defined as severely stunted.

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Height-for-age Z-score (HAZ)	-3.77 z score Standard Deviation 1.98	-3.64 z score Standard Deviation 1.49

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days)

Mid-upper arm circumference (centimeters) will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit).

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Mid-upper Arm Circumference (MUAC)	12.70 centimeters (cm) Standard Deviation 0.70	12.73 centimeters (cm) Standard Deviation 0.52

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days)

Weight will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit) and weight-for-age z-scores will be calculated.

Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards

A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WAZ < -2 standard distributions below the median is defined as underweight, while a WAZ < -3 standard distributions below the median is defined as severely underweight.

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Weight-for-age Z-score (WAZ)	-2.67 z score Standard Deviation 1.31	-2.48 z score Standard Deviation 0.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days)

Weight and height, assessed at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit), will be used to calculate weight-for-height z-scores.

Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards

A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ < -2 standard distributions below the median is defined as moderately wasted, while a WAZ < -3 standard distributions below the median is defined as severely wasted.

Outcome measures

Measure	Amoxicillin n=42 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=58 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Weight-for-height Z-score (WHZ)	-0.69 z score Standard Deviation 1.44	-0.60 z score Standard Deviation 1.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: 55 children in Amoxicillin arm and 66 children in Azithromycin arm had malaria test between the 8 weeks window (42 to 70 days)

Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status. Positivity rate will be compared between arms

Outcome measures

Measure	Amoxicillin n=55 Participants Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=66 Participants Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Malaria	9 Participants	16 Participants

Adverse Events

Amoxicillin

Serious events: 1 serious events

Other events: 1 other events

Deaths: 4 deaths

Azithromycin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Measure	Amoxicillin n=133 participants at risk Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=142 participants at risk Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
General disorders Death in 7 days	0.75% 1/133 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.	0.00% 0/142 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.

Other adverse events

Measure	Amoxicillin n=133 participants at risk Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.	Azithromycin n=142 participants at risk Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
General disorders weight loss	0.75% 1/133 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.	0.70% 1/142 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.
General disorders severe fever	0.00% 0/133 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.	0.70% 1/142 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.
Gastrointestinal disorders vomiting	0.00% 0/133 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.	0.70% 1/142 • Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks. Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days. All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.

Additional Information

Dr. Catherine E. Oldenburg

UCSF FI Proctor

Phone: 415-502-8843

Email: catherine.oldenburg@ucsf.edu

Results disclosure agreements

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