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

Epicentre

Status: Completed

Conditions: Severe Acute Malnutrition

Treatments: Drug: Amoxicillin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01613547

EPI/NIGER/821242

Details and patient eligibility

About

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.

Enrollment: 2,412 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,412 participants in 2 patient groups, including a placebo group

Routine antibiotic prescription

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin

No routine antibiotic prescription

Placebo Comparator group

Treatment:

Drug: Placebo