Standard Medical Care
OtherAll 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.
NCT Number: NCT03370003
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.
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Notify Me6 month–59 month
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study participation, no more than 2 months after follow-up of the last participant
Primary outcome will be measured in the field of nutrition, hospitalization, death and abandonment in the observation site (s) with that observed in 3 comparison groups:
Epicentre
Other
Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children
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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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