- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473234
Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Catherine E Oldenburg, ScD
- Phone Number: 4155028843
- Email: catherine.oldenburg@ucsf.edu
Study Contact Backup
- Name: Hadley R Burroughs, MSPH
- Phone Number: 4155022521
- Email: Hadley.burroughs@ucsf.edu
Study Locations
-
-
Gombe State
-
Gombe, Gombe State, Nigeria, 760252
- The Tamaika Project
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria (all must be met):
- Age 6-59 months
- Weight-for-height z-score (WHZ) < -3 SD or mid-upper arm circumference (MUAC) < 115 mm
- No nutritional or nutritional edema Grade I and II
- Primary residence within catchment area of enrollment site
- Available for full 8-week study
- Has not been admitted to a nutritional program for the treatment of severe acute malnutrition (SAM) in the 2 preceding weeks
- No antibiotic use in past 7 days
- No clinical complications requiring antibiotic treatment
- No clinical complications requiring inpatient treatment
- No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, sickle cell disease, etc)
- No allergy to macrolides/azalides
- Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
- Appropriate written informed consent from at least one parent or guardian
Exclusion criteria (any excludes):
- Age < 6 months or > 59 months
- WHZ ≥ -3 SD or MUAC ≥ 115 mm
- Primary residence outside catchment area of enrollment site
- Not available for full 8-week study
- Presence of nutritional edema Grade III
- Admission to a nutritional program for the treatment of SAM in the 2 preceding weeks
- Antibiotic use in past 7 days
- Clinical complications requiring antibiotic treatment
- Clinical complications requiring inpatient treatment
- Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
- Allergy to macrolides/azalides
- Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
- Parent or guardian refuses to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Azithromycin
Children in this arm will receive one dose of amoxicillin.
|
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.
|
Active Comparator: Amoxicillin
Children in this arm will receive a 5-day course of amoxicillin (standard care).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Gain at 8 weeks
Time Frame: 8 weeks
|
Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/kg/day
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional Recovery at 8 weeks
Time Frame: 8 weeks
|
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. |
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Gain over 12 weeks
Time Frame: 12 weeks
|
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/kg/day).
|
12 weeks
|
Time to recovery
Time Frame: 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.
|
12 weeks
|
Nonresponse at 8 weeks
Time Frame: 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.
|
8 weeks
|
Transfer to inpatient care
Time Frame: 12 weeks
|
The occurrence, date, and reason for transfer from outpatient to inpatient treatment will be recorded.
|
12 weeks
|
Mortality by 8 weeks
Time Frame: 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.
|
8 weeks
|
Mortality by 12 weeks
Time Frame: 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.
|
12 weeks
|
Clinical signs of infection
Time Frame: 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
|
12 weeks
|
Height-for-age z-score (HAZ)
Time Frame: 12 weeks
|
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. |
12 weeks
|
Mid-upper arm circumference (MUAC)
Time Frame: 12 weeks
|
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).
|
12 weeks
|
Weight-for-age z-score (WAZ)
Time Frame: 12 weeks
|
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. |
12 weeks
|
Weight-for-height z-score (WHZ)
Time Frame: 12 weeks
|
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. |
12 weeks
|
Malaria
Time Frame: 8 weeks
|
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
|
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kieran S O'Brien, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-36912
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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