Clinical trial NCT05473234: Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Official title: Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Severe Acute Malnutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: The Taimaka Project
First posted: 2022-07-25
Enrollment: 310
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight Gain at 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants With Nutritional Recovery at 8 Weeks
timeFrame: 8 weeks
Other outcomes:
measure: Weight Gain Over 12 Weeks
timeFrame: 12 weeks
measure: Time to Recovery
timeFrame: 12 weeks
measure: Nonresponse at 8 Weeks
timeFrame: 8 weeks
measure: Number of Participants Who Transferred to Inpatient Care
timeFrame: 12 weeks
measure: Mortality by 8 Weeks
timeFrame: 8 weeks
measure: Mortality by 12 Weeks
timeFrame: 12 weeks
measure: Clinical Signs of Infection
timeFrame: 12 weeks
measure: Height-for-age Z-score (HAZ)
timeFrame: 12 weeks
measure: Mid-upper Arm Circumference (MUAC)
timeFrame: 12 weeks
measure: Weight-for-age Z-score (WAZ)
timeFrame: 12 weeks
measure: Weight-for-height Z-score (WHZ)
timeFrame: 12 weeks
measure: Malaria
timeFrame: 8 weeks
Locations:
city: Gombe
country: Nigeria
facility: The Tamaika Project
state: Gombe State
Study officials:
affiliation: University of California, San Francisco
name: Kieran S O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References: