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

Severe Acute Malnutrition Clinical Trial

Official title:

The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613547
• Other study ID #: EPI/NIGER/821242
• Status: Completed
• Phase: N/A
• First received: May 26, 2012
• Last updated: May 20, 2014
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Niger: Ministere de la Sante PubliqueFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2412
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Drug:
• Amoxicillin
80 mg/kg/day for 7 days
• Placebo
7 days

Locations

Country	Name	City	State
Niger	Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi	Maradi

Sponsors (6)

Lead Sponsor	Collaborator
Epicentre	Bichat Hospital, District Sanitaire de Madarounfa, Région de Maradi, FORSANI, Medecins Sans Frontieres, Ministere de la Sante Publique du Niger

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children discharged from nutritional program as recovered		Until discharge from the nutritional program, an expected average of 5 weeks	No
Secondary	Hospitalization or death		3 months following enrollment