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Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

Primary Purpose

Severe Acute Malnutrition

Status
Recruiting
Phase
Phase 3
Locations
Nigeria
Study Type
Interventional
Intervention
Azithromycin
Amoxicillin
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Tamaika ProjectRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azithromycin

Amoxicillin

Arm Description

Children in this arm will receive one dose of amoxicillin.

Children in this arm will receive a 5-day course of amoxicillin (standard care).

Outcomes

Primary Outcome Measures

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/kg/day

Secondary Outcome Measures

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.

Full Information

First Posted
July 11, 2022
Last Updated
February 1, 2023
Sponsor
University of California, San Francisco
Collaborators
The Taimaka Project
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1. Study Identification

Unique Protocol Identification Number
NCT05473234
Brief Title
Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Official Title
Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
The Taimaka Project

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
Children in this arm will receive one dose of amoxicillin.
Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Description
Children in this arm will receive a 5-day course of amoxicillin (standard care).
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Gain at 8 weeks
Description
Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/kg/day
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Nutritional Recovery at 8 weeks
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Weight Gain over 12 weeks
Description
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).
Time Frame
12 weeks
Title
Time to recovery
Description
Time from enrollment to nutritional recovery will be calculated in days by subtracting the date of enrollment from the date of nutritional recovery.
Time Frame
12 weeks
Title
Nonresponse at 8 weeks
Description
Number of children with nonresponse will be documented if a child does not meet the criteria for nutritional recovery at 8 weeks after enrollment.
Time Frame
8 weeks
Title
Transfer to inpatient care
Description
The occurrence, date, and reason for transfer from outpatient to inpatient treatment will be recorded.
Time Frame
12 weeks
Title
Mortality by 8 weeks
Description
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.
Time Frame
8 weeks
Title
Mortality by 12 weeks
Description
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.
Time Frame
12 weeks
Title
Clinical signs of infection
Description
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
Time Frame
12 weeks
Title
Height-for-age z-score (HAZ)
Description
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.
Time Frame
12 weeks
Title
Mid-upper arm circumference (MUAC)
Description
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).
Time Frame
12 weeks
Title
Weight-for-age z-score (WAZ)
Description
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.
Time Frame
12 weeks
Title
Weight-for-height z-score (WHZ)
Description
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.
Time Frame
12 weeks
Title
Malaria
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine E Oldenburg, ScD
Phone
4155028843
Email
catherine.oldenburg@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hadley R Burroughs, MSPH
Phone
4155022521
Email
Hadley.burroughs@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kieran S O'Brien, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Tamaika Project
City
Gombe
State/Province
Gombe State
ZIP/Postal Code
760252
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abubakar Umar, MBBS
Phone
2348061307990
Email
abubakar@taimaka.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

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