Trial | NCT01613547  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2412
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.
Study Started
Oct 31
2012
Primary Completion
Mar 31
2014
Study Completion
May 31
2014
Last Update
May 21
2014
Estimate

Drug Amoxicillin

80 mg/kg/day for 7 days

Drug Placebo

7 days

Routine antibiotic prescription Active Comparator

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

No routine antibiotic prescription Placebo Comparator

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
No Results Posted