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OpenTrials
Completed

NCT Number: NCT01613547

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

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.

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Key information

Conditions

Severe Acute Malnutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi

Maradi, Niger

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

80 mg/kg/day for 7 days

Placebo

Drug

7 days

Primary outcomes

  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 outcomes

  1. Hospitalization or death

    Time frame: 3 months following enrollment

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Bichat Hospital
  • District Sanitaire de Madarounfa, Région de Maradi
  • FORSANI
  • Medecins Sans Frontieres, Netherlands
  • Ministere de la Sante Publique du Niger

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2012
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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