Clinical trial NCT01613547: The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications
Official title: The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Medecins Sans Frontieres, Netherlands
name: FORSANI
name: District Sanitaire de Madarounfa, Région de Maradi
name: Ministere de la Sante Publique du Niger
name: Bichat Hospital
First posted: 2012-06-07
Enrollment: 2412
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 study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.


Eligibility criteria: Inclusion Criteria:

* Age from 6 to 59 months
* MUAC \< 11.5 cm or WHZ \< -3
* Absence of bipedal edema
* Absence of current illness requiring inpatient care
* Eligible for new admission for outpatient nutritional therapy for SAM at 3 CRENAS in Madarounfa operated by FORSANI
* Absence of current clinical illness requiring prescription of specific antibiotic therapy and decision by the study physician to use a specific antimicrobial drug on admission
* Written consent of parent or caregiver
* Residence within Niger

Exclusion Criteria:

* Age \< 6 months or \> 59 months
* MUAC ≥ 11.5 cm and WHZ ≥ -3
* Presence of bipedal edema
* Presence of current illness requiring inpatient care
* Decision by the study physician to use a specific different antimicrobial drug on admission
* Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
* Treatment with any antibiotic within 7 days
* Admission to any nutritional program for the treatment of SAM within 3 months
* Known contraindication / hypersensitivity to amoxicillin

Primary outcomes:
measure: Proportion of children discharged from nutritional program as recovered
timeFrame: Until discharge from the nutritional program, an expected average of 5 weeks
Secondary outcomes:
measure: Hospitalization or death
timeFrame: 3 months following enrollment
Other outcomes:
Locations:
city: Maradi
country: Niger
facility: Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi
Study officials:
affiliation: Epicentre
name: Sheila Isanaka, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bliznashka L, Grantz KH, Botton J, Berthe F, Garba S, Hanson KE, Grais RF, Isanaka S. Burden and risk factors for relapse following successful treatment of uncomplicated severe acute malnutrition in young children: Secondary analysis from a randomised trial in Niger. Matern Child Nutr. 2022 Oct;18(4):e13400. doi: 10.1111/mcn.13400. Epub 2022 Jul 21.
citation: Maataoui N, Langendorf C, Berthe F, Bayjanov JR, van Schaik W, Isanaka S, Grais RF, Clermont O, Andremont A, Armand-Lefevre L, Woerther PL. Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin. J Antimicrob Chemother. 2020 Mar 1;75(3):709-717. doi: 10.1093/jac/dkz487.
citation: Madzorera I, Duggan C, Berthe F, Grais RF, Isanaka S. The role of dietary diversity in the response to treatment of uncomplicated severe acute malnutrition among children in Niger: a prospective study. BMC Nutr. 2018 Sep 20;4:35. doi: 10.1186/s40795-018-0242-y. eCollection 2018.
citation: Oldenburg CE, Guerin PJ, Berthe F, Grais RF, Isanaka S. Malaria and Nutritional Status Among Children With Severe Acute Malnutrition in Niger: A Prospective Cohort Study. Clin Infect Dis. 2018 Sep 14;67(7):1027-1034. doi: 10.1093/cid/ciy207.
citation: Isanaka S, Langendorf C, Berthe F, Gnegne S, Li N, Ousmane N, Harouna S, Hassane H, Schaefer M, Adehossi E, Grais RF. Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children. N Engl J Med. 2016 Feb 4;374(5):444-53. doi: 10.1056/NEJMoa1507024.