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

This study is currently recruiting participants.
Verified October 2012 by Epicentre
Sponsor:
Collaborators:
Médecins Sans Frontières France
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: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Severe Acute Malnutrition
 Drug: Amoxicillin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Epicentre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Hospitalization or death [ Time Frame: 3 months following enrollment ]

Estimated Enrollment: 2412
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Routine antibiotic prescription
Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)
 Drug: Amoxicillin
80 mg/kg/day for 7 days
Placebo Comparator: No routine antibiotic prescription Drug: Placebo
7 days

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613547

Contacts
Contact: Sheila Isanaka, ScD + 33.1.4021.5498 sheila.isanaka@epicentre.msf.org

Locations
Niger
Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi Recruiting
Maradi, Niger
Contact: Sheila Isanaka, ScD            
Sponsors and Collaborators
Epicentre
Médecins Sans Frontières France
FORSANI
District Sanitaire de Madarounfa, Région de Maradi
Ministere de la Sante Publique du Niger
Bichat Hospital
Investigators
Principal Investigator: Sheila Isanaka, ScD Epicentre
  More Information

No publications provided

Responsible Party: Sheila Isanaka, Prinicipal Investigator, Epicentre
ClinicalTrials.gov Identifier: NCT01613547     History of Changes
Other Study ID Numbers: EPI/NIGER/821242
Study First Received: May 26, 2012
Last Updated: October 29, 2012
Health Authority: Niger: Ministere de la Sante Publique
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Amoxicillin
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013