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Non-routine Use of Antibiotics (Amoxi-light)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370003
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Médecins Sans Frontières, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Severe Acute Malnutrition Other: Standard medical care

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.

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Study Type : Observational
Actual Enrollment : 2876 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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:

    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370003


Sponsors and Collaborators
Epicentre
Médecins Sans Frontières, France
Investigators
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Study Director: Rebecca GRAIS, PhD Epicentre
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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT03370003    
Other Study ID Numbers: NE-914
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The results of the study will be regularly communicated to all partners. A scientific article will be prepared and presented to the reading committee of a specialized journal, as well as to international symposia, in order to allow wide dissemination to the scientific community.

MSF standard policy on data sharing will apply.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders