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Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children
To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and hospitalization with non-routine use of amoxicillin compared to the risk achieved with systematic use of antibiotics.
Upon admission, all children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics. Antibiotics will be provided at admission and during follow-up only if clinically justified. The results of the program (ie, nutritional recovery, hospitalization, death and abandonment) will be monitored in all children aged 6 to 59 months admitted for outpatient therapy in 2 outpatient treatment sites in the Madarounfa health district in Niger. To ensure that the children included in the study receive appropriate care, the study will ask the children's leaders to return to the clinic for medical surveillance in the event of a clinical complication. Program staff will facilitate appropriate management, including prescription of antibiotics if clinically justified, and transfer to hospital of all children in need of close supervision and / or comprehensive medical management.
Age
0 - 4 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 1, 2016
Primary Completion Date
September 29, 2017
Completion Date
December 31, 2018
Last Updated
August 14, 2019
2,876
ACTUAL participants
Standard medical care
OTHER
Lead Sponsor
Epicentre
Collaborators
NCT06154174
NCT06869850
Data Source & Attribution
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