Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02839551
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Doses for Drug Provocation Tests to Beta-lactams
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004342', 'term': 'Drug Hypersensitivity'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the new simplified drug provocation test', 'timeFrame': 'up to 1 hour', 'description': 'Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Betalactams', 'Drug hypersensitivity', 'Drug provocation test', 'Reactive dose'], 'conditions': ['Drug Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.\n\ninvestigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with positive Drug Provocation Test (DPT) to beta-lactams\n\nExclusion Criteria:\n\n* contra-indications to DPT\n* refusal of participation\n* vulnerable patients according to French regulation'}, 'identificationModule': {'nctId': 'NCT02839551', 'acronym': 'NewBL', 'briefTitle': 'Optimal Doses for Drug Provocation Tests to Beta-lactams', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity', 'orgStudyIdInfo': {'id': 'RECHMPL15_0269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simplified drug provocation test', 'description': 'Assessment of the Hypersensitivity to betalactams by simplified drug provocation test', 'interventionNames': ['Procedure: simplified drug provocation test']}], 'interventions': [{'name': 'simplified drug provocation test', 'type': 'PROCEDURE', 'description': 'Assessment of the Hypersensitivity to betalactams by simplified drug provocation test', 'armGroupLabels': ['Simplified drug provocation test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'France', 'country': 'France', 'facility': 'University hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}