Non-routine Use of Antibiotics (Amoxi-light)

NCT03370003 | Completed

• 1 other identifier: NE-914
• Study Type: observational
• Target: 2,876
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• Evaluation of nutritional recovery

  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)

  Through study participation, no more than 2 months after follow-up of the last participant

Interventions

Standard medical care OTHER

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.

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epicentre: lead
• Médecins Sans Frontières, France: collaborator

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rebecca GRAIS, PhD

  Epicentre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 12, 2017
• Study Start: September 1, 2016
• Primary Completion: September 29, 2017
• Study Completion: December 31, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share