Non-routine Use of Antibiotics (Amoxi-light)
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|ClinicalTrials.gov Identifier: NCT03370003|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment|
|Severe Acute Malnutrition||Other: Standard medical care|
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.
|Study Type :||Observational|
|Actual Enrollment :||2876 participants|
|Official Title:||Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||September 29, 2017|
|Actual Study Completion Date :||December 31, 2018|
- Other: Standard medical care
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.
- Evaluation of nutritional recovery [ 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:
- Children receiving amoxicillin and placebo in the randomized trial conducted by MSF (2012-2014)
- Children receiving amoxicillin in MSF program sites not selected for study in Madarounfa (2016)
- Children receiving amoxicillin at selected sites from the previous year (2015)
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): NCT03370003
|Study Director:||Rebecca GRAIS, PhD||Epicentre|