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Azithromycin for Uncomplicated Severe Acute Malnutrition in Niger (Pilot)

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ClinicalTrials.gov Identifier: NCT03568643
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : July 22, 2019
Sponsor:
Collaborators:
Centre de Recherche et Interventions en Sante Publique (CRISP)
Francis I. Proctor Foundation, University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Niger who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed them at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.

Condition or disease Intervention/treatment Phase
Uncomplicated Severe Acute Malnutrition Drug: Azithromycin Drug: Amoxicillin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition: A Individual-randomized Pilot Trial of the Effect of a Single Dose of Oral Azithromycin on Weight Gain in Uncomplicated Severe Acute Malnutrition in Niger
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Azithromycin Drug: Azithromycin
Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Other Name: Zithromax

Active Comparator: Amoxicillin Drug: Amoxicillin
Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Niger guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.




Primary Outcome Measures :
  1. Nutritional recovery [ Time Frame: 8 weeks ]
    Nutritional recovery is defined as a child having WHZ ≥ -2 on two consecutive visits with MUAC of ≥ 115 mm and no acute complication or edema for the past 7 days.


Secondary Outcome Measures :
  1. Malaria [ Time Frame: 8 weeks ]
    Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.

  2. Time to recovery [ Time Frame: 8 weeks ]
    Time from enrollment to nutritional recovery (defined above) will be recorded.

  3. Mortality [ Time Frame: 8 weeks ]
    Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.

  4. Adverse events [ Time Frame: 8 weeks ]
    Adverse events will be reported at all follow-up time points

  5. HAZ [ Time Frame: 8 weeks ]
    Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated.

  6. MUAC [ Time Frame: 8 weeks ]
    Mid-upper arm circumference will be measured at all follow-up time points.

  7. WAZ [ Time Frame: 8 weeks ]
    Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated.

  8. WHZ [ Time Frame: 8 weeks ]
    Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores.

  9. Weight gain [ Time Frame: 8 weeks ]
    Weight will be measured at all follow-up time points and weight gain will be defined as grams per kilogram per day (g/kg/day).



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6-59 months
  • WHZ <-3 SD or MUAC <115 mm
  • Weight >= 3.8 kg
  • No nutritional edema
  • Able and willing to participate in full 8-week study
  • Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
  • No antibiotic use in past 7 days
  • No clinical complications requiring inpatient treatment (except for routine admission for children <6 months)
  • 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, etc)
  • No allergy to macrolides/azalides
  • Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
  • Appropriate consent from at least one parent or guardian

Exclusion Criteria:

  • Age <6 months or >59 months
  • WHZ ≥-3 SD or MUAC ≥115 mm
  • Weight < 3.8 kg
  • Nutritional edema
  • Not able or willing to participate in full 8-week study
  • Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
  • Antibiotic use in past 7 days
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568643


Contacts
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Contact: Kieran S O'Brien, MPH 4155142163 kieran.obrien@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Centre de Recherche et Interventions en Sante Publique (CRISP)
Francis I. Proctor Foundation, University of California, San Francisco
Investigators
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Principal Investigator: Catherine E Oldenburg, ScD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03568643     History of Changes
Other Study ID Numbers: 18-25274
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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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

Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents