NCT01613547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

May 26, 2012

Last Update Submit

May 20, 2014

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Proportion of children discharged from nutritional program as recovered

    Until discharge from the nutritional program, an expected average of 5 weeks

Secondary Outcomes (1)

  • Hospitalization or death

    3 months following enrollment

Study Arms (2)

Routine antibiotic prescription

ACTIVE COMPARATOR

Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)

Drug: Amoxicillin

No routine antibiotic prescription

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AmoxicillinDRUG

80 mg/kg/day for 7 days

Routine antibiotic prescription
PlaceboDRUG

7 days

No routine antibiotic prescription

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi

Maradi, Niger

Location

Related Publications (7)

  • 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.

    PMID: 38966095DERIVED

  • 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.

    PMID: 37866373DERIVED

  • 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.

    PMID: 35866201DERIVED

  • 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.

    PMID: 32153896DERIVED

  • 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.

    PMID: 31821452DERIVED

  • 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.

    PMID: 29522089DERIVED

  • 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.

    PMID: 26840134DERIVED

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sheila Isanaka, ScD

    Epicentre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

May 26, 2012

First Posted

June 7, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

NI(1)