Non-routine Use of Antibiotics (Amoxi-light)

Completed

• Conditions: Severe Acute Malnutrition

• Registration Number: NCT03370003
• Lead Sponsor: Epicentre

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.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-09-29
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-12
• Study Completion: 2018-12-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2876

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of nutritional recovery	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: 1. Children receiving amoxicillin and placebo in the randomized trial conducted by MSF (2012-2014); 2. Children receiving amoxicillin in MSF program sites not selected for study in Madarounfa (2016); 3. Children receiving amoxicillin at selected sites from the previous year (2015)