Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-29 @ 1:10 AM
Study NCT ID:
NCT04922034
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Patients After a Negative Oral Challenge to Amoxicillin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resumption of Amoxicillin after a negative oral challenge to Amoxicillin', 'timeFrame': 'Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call', 'description': 'The main objective is to know if patients who had a negative test for reintroduction of Amoxicillin, have resumed this molecule afterwards.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['penicillins', 'reintroduction'], 'conditions': ['Negative Challenge to Amoxicillin']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin', 'detailedDescription': 'This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed at Angers University Hospital between 2017 and 2019.\n\nAn information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective, single-center, non-interventionnel study of patients with a negative oral challenge to Amoxicillin at Angers University Hospital between 2017 and 2019.\n\nAn information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone one month after the information letter is sent, to answer the questionnaire. This questionnaire, filled in during the telephone interview, concerns the resumption or not of penicillins since the reintroduction test.\n\nThis study concerns all patients, agreeing to participate in this study, who had a negative challenge test to Amoxicillin at the CHU of Angers from 2017 to 2019.\n\nThe potential inclusion is approximately 200 individuals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019.\n* Major patients.\n\nExclusion Criteria:\n\n* Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire\n* Person objecting to participate in this research and to the processing of their medical data'}, 'identificationModule': {'nctId': 'NCT04922034', 'acronym': 'REINAD', 'briefTitle': 'Outcome of Patients After a Negative Oral Challenge to Amoxicillin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Study of Patient's Outcomes After a Negative Reintroduction Test for Amoxicillin", 'orgStudyIdInfo': {'id': '49RC21_0178'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Outcome of patients with negative oral challenge to amoxicillin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'state': 'Maine Et Loire', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}