Clinical trial NCT03370003: Non-routine Use of Antibiotics (Amoxi-light)
Official title: Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Malnutrition
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Médecins Sans Frontières, France
First posted: 2017-12-12
Enrollment: 2876
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children from 6 to 59 months admitted directly for the treatment of uncomplicated SAM(MUAC \<115 mm or PTZ \<-3 and / or presence of nutritional edema grade + or + + and moderate or good appetite with no medical complications) in the 2 CRENAS chosen as study sites during the inclusion period of the study. A "direct admission" is defined as an admission without reference from CRENI (intensive nutritional recovery and education centres) to CRENAS. Readmission cases, that is, children admitted to the nutritional program in the last 3 months, and references from the Center for Ambulatory Nutritional Recovery for Moderates (CRENAM) remain eligible for inclusion of the study without prejudice and without notation at the previous admission.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 6-59 months
* Direct admission for the treatment of uncomplicated SAM (MUAC \<115 mm or PTZ \<-3 and / or presence of Grade + or ++ nutritional edema and moderate or good appetite with absence of medical complications)
* Signed Informed Consent

Exclusion Criteria:

* No Informed Consent given
* Not directly admitted for the treatment of uncomplicated SAM at the CRENAS (Center for Outpatient Nutritional Rehabilitation for Malnutrition) of the study

Primary outcomes:
measure: Evaluation of nutritional recovery
timeFrame: Through study participation, no more than 2 months after follow-up of the last participant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Epicentre
name: Rebecca GRAIS, PhD
role: STUDY_DIRECTOR
References: