Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-03-04 @ 7:31 AM
Study NCT ID:
NCT03370003
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2017-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-routine Use of Antibiotics (Amoxi-light)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2876}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of nutritional recovery', 'timeFrame': 'Through study participation, no more than 2 months after follow-up of the last participant', 'description': '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:\n\n1. Children receiving amoxicillin and placebo in the randomized trial conducted by MSF (2012-2014)\n2. Children receiving amoxicillin in MSF program sites not selected for study in Madarounfa (2016)\n3. Children receiving amoxicillin at selected sites from the previous year (2015)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Acute Malnutrition']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6-59 months\n* 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)\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* No Informed Consent given\n* Not directly admitted for the treatment of uncomplicated SAM at the CRENAS (Center for Outpatient Nutritional Rehabilitation for Malnutrition) of the study'}, 'identificationModule': {'nctId': 'NCT03370003', 'briefTitle': 'Non-routine Use of Antibiotics (Amoxi-light)', 'organization': {'class': 'OTHER', 'fullName': 'Epicentre'}, 'officialTitle': 'Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children', 'orgStudyIdInfo': {'id': 'NE-914'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Standard medical care', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rebecca GRAIS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Epicentre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.\n\nMSF standard policy on data sharing will apply.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epicentre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Médecins Sans Frontières, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}