Non-routine Use of Antibiotics (Amoxi-light)

Severe Acute Malnutrition Clinical Trial

Official title:

Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370003
• Other study ID #: NE-914
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2876
• Est. completion date: December 31, 2018
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	Médecins Sans Frontières, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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)	Through study participation, no more than 2 months after follow-up of the last participant