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The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

Primary Purpose

Severe Acute Malnutrition

Status

Completed

Phase

Not Applicable

Locations

Niger

Study Type

Interventional

Intervention

Amoxicillin

Placebo

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:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Routine antibiotic prescription

No routine antibiotic prescription

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of children discharged from nutritional program as recovered

Secondary Outcome Measures

Hospitalization or death

Full Information

NCT ID

NCT01613547

First Posted

May 26, 2012

Last Updated

May 20, 2014

Sponsor

Epicentre

Collaborators

Medecins Sans Frontieres, Netherlands, FORSANI, District Sanitaire de Madarounfa, Région de Maradi, Ministere de la Sante Publique du Niger, Bichat Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01613547

Brief Title

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

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Epicentre

Collaborators

Medecins Sans Frontieres, Netherlands, FORSANI, District Sanitaire de Madarounfa, Région de Maradi, Ministere de la Sante Publique du Niger, Bichat Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Routine antibiotic prescription

Arm Type

Active Comparator

Arm Description

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

Arm Title

No routine antibiotic prescription

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

80 mg/kg/day for 7 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

7 days

Primary Outcome Measure Information:

Title

Proportion of children discharged from nutritional program as recovered

Time Frame

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

Secondary Outcome Measure Information:

Title

Hospitalization or death

Time Frame

3 months following enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheila Isanaka, ScD

Organizational Affiliation

Epicentre

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Maradi

Country

Niger

12. IPD Sharing Statement

Citations:

PubMed Identifier

35866201

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.

Results Reference

derived

PubMed Identifier

31821452

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.

Results Reference

derived

PubMed Identifier

32153896

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.

Results Reference

derived

PubMed Identifier

29522089

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.

Results Reference

derived

PubMed Identifier

26840134

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.

Results Reference

derived

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The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

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