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OpenTrials
Completed

NCT Number: NCT03370003

Non-routine Use of Antibiotics (Amoxi-light)

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of nutritional recovery

    Time frame: 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:

    • 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)

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Médecins Sans Frontières, France

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 12, 2017
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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