Severe Acute MalnutritionPhase 3NCT05473234
Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
A Phase 3 study testing Azithromycin and Amoxicillin in people with Severe Acute Malnutrition, run by University of California, San Francisco at 1 site in Nigeria.
Trial summary
This randomized controlled trial is designed to determine the effect of administration of azithromycin compared to amoxicillin as part of the treatment of uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months on weight gain and nutritional recovery. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Azithromycin and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteNigeria
- Study dates
- 6 Oct 2022to 29 Nov 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial is designed to determine the effect of administration of azithromycin compared to amoxicillin as part of the treatment of uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months on weight gain and nutritional recovery. The investigators will randomize children presenting to Taimaka-run nutritional programs at health centers in Gombe State, Nigeria to a single dose of oral azithromycin or a short course of oral amoxicillin upon admission into the program. Apart from the administration of antibiotics, all children will receive standard outpatient treatment for uncomplicated SAM as specified in the guidelines of the government of Nigeria, which includes therapeutic feeding with ready-to-use therapeutic food (RUTF). Enrolled children will be followed weekly at each routine clinic follow-up visit up until nutritional recovery. All enrolled children will return for a final study visit at 8 weeks following enrollment. Anthropometric and vital status data will be collected at each follow-up visit. Weight gain and nutritional recovery over the 8-week study period will be compared by arm as a primary outcome and at 12 weeks as a secondary outcome.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Azithromycin, Amoxicillin
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
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.
AmoxicillinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | Children in this arm will receive one dose of amoxicillin. Receives: Drug: Azithromycin |
| Amoxicillin | Active comparator | Children in this arm will receive a 5-day course of amoxicillin (standard care). Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain at 8 Weeks
Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day
Measured: 8 weeks
Secondary outcomes (1)
Number of Participants With Nutritional Recovery at 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start6 Oct 2022
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Why it stopped: Study was halted due to low follow-up rates and issues with data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- The Taimaka Project
- Responsible party
- Sponsor
- Investigators
- Kieran S O'Brien, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473234
- Sponsor's protocol ID
- 22-36912
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2022
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No