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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medecins Sans Frontieres
FORSANI
District Sanitaire de Madarounfa, Région de Maradi
Ministere de la Sante Publique du Niger
Bichat Hospital
Information provided by (Responsible Party):
Sheila Isanaka, Epicentre
ClinicalTrials.gov Identifier:
NCT01613547
First received: May 26, 2012
Last updated: November 19, 2013
Last verified: November 2013

May 26, 2012
November 19, 2013
October 2012
March 2014   (final data collection date for primary outcome measure)
Proportion of children discharged from nutritional program as recovered [ Time Frame: Until discharge from the nutritional program, an expected average of 5 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01613547 on ClinicalTrials.gov Archive Site
Hospitalization or death [ Time Frame: 3 months following enrollment ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Severe Acute Malnutrition
  • Drug: Amoxicillin
    80 mg/kg/day for 7 days
  • Drug: Placebo
    7 days
  • Active Comparator: Routine antibiotic prescription
    Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)
    Intervention: Drug: Amoxicillin
  • Placebo Comparator: No routine antibiotic prescription
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2412
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Niger
 
NCT01613547
EPI/NIGER/821242
No
Sheila Isanaka, Epicentre
Epicentre
  • Medecins Sans Frontieres
  • FORSANI
  • District Sanitaire de Madarounfa, Région de Maradi
  • Ministere de la Sante Publique du Niger
  • Bichat Hospital
Principal Investigator: Sheila Isanaka, ScD Epicentre
Epicentre
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP