An interventional study of Amoxicillin and Placebo in Severe Acute Malnutrition, sponsored by Epicentre. Completed at 1 site in Niger. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2014-05-21.
Sponsored by Epicentre · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Severe Acute Malnutrition; 13 are open to participants now.
This study's planned enrollment of 2,412 is above the median of 400 across 69 interventional studies indexed under Severe Acute Malnutrition.
Browse Severe Acute Malnutrition studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)
Drug: Amoxicillin
Drug: Placebo
80 mg/kg/day for 7 days
7 days
Proportion of children discharged from nutritional program as recovered
Time frame: Until discharge from the nutritional program, an expected average of 5 weeks
Hospitalization or death
Time frame: 3 months following enrollment
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Epicentre