Non-routine Use of Antibiotics (Amoxi-light)

Epicentre

Status: Completed

Conditions: Severe Acute Malnutrition

Treatments: Other: Standard medical care

Study type: Observational

Funder types: Other

Identifiers

NCT03370003

NE-914

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,876 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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