drugset / Trial / NCT01613547
The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications
Completed
2412 enrolled
Epicentre
Bichat Hospital · collabDistrict Sanitaire de Madarounfa, Région de Maradi · collabFORSANI · collabMedecins Sans Frontieres, Netherlands · collabMinistere de la Sante Publique du Niger · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2012-10
- Primary completion
- 2014-03
- Completion
- 2014-05
Publications
- Rattigan SM, Grantz KH, Hanson K, Langendorf C, Berthe F, Grais R, Isanaka S. Prescribing practices in the treatment of wasting: secondary analysis from a randomised trial. BMJ Nutr Prev Health. 2024 Feb 26;7(1):103-111. doi: 10.1136/bmjnph-2023-000785. eCollection 2024.
- Schwartz DJ, Langdon A, Sun X, Langendorf C, Berthe F, Grais RF, Trehan I, Isanaka S, Dantas G. Effect of amoxicillin on the gut microbiome of children with severe acute malnutrition in Madarounfa, Niger: a retrospective metagenomic analysis of a placebo-controlled trial. Lancet Microbe. 2023 Nov;4(11):e931-e942. doi: 10.1016/S2666-5247(23)00213-6. Epub 2023 Oct 19.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 80 mg/kg | — |