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

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ClinicalTrials.gov Identifier: NCT01613547
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : May 21, 2014
Sponsor:
Collaborators:
Medecins Sans Frontieres, Netherlands
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

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Acute Malnutrition Drug: Amoxicillin Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Amoxicillin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of children discharged from nutritional program as recovered [ Time Frame: Until discharge from the nutritional program, an expected average of 5 weeks ]

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


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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613547


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila Isanaka, Prinicipal Investigator, Epicentre
ClinicalTrials.gov Identifier: NCT01613547     History of Changes
Other Study ID Numbers: EPI/NIGER/821242
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents