Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-06-09 @ 9:18 PM
Study NCT ID:
NCT05264402
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.', 'timeFrame': 'first 30 days after placement', 'description': 'catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.\n\nthe number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline'}], 'secondaryOutcomes': [{'measure': 'catheter placement time will be evaluated in days', 'timeFrame': 'first 30 days after placement', 'description': 'catheter placement time will be evaluted by measuring the time between catheter placement and removal in days'}, {'measure': 'rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications', 'timeFrame': 'first 30 days', 'description': 'The number of mechanical compliaction (obstruction, accidental removal, etc.), haemorrhagic and thrombotic complications recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['venous access', 'Midline', 'PICC line', 'catheter-related bloodstream infections'], 'conditions': ['Catheter-related Bloodstream Infection']}, 'descriptionModule': {'briefSummary': 'A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.\n\nIf the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.\n\nThe aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.', 'detailedDescription': 'This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.\n\nCatheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring a vascular approach using PICCline or Midline catheters', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major ≥ 18 years old\n* opposition formulated\n\nExclusion Criteria:\n\n* Refusal of participation\n* Patients under legal protection (guardianship, curatorship, etc.)'}, 'identificationModule': {'nctId': 'NCT05264402', 'acronym': 'PICCORMID', 'briefTitle': 'Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS', 'orgStudyIdInfo': {'id': 'PICCORMID (29BRC21.0288)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PICCline group', 'description': 'Patients needing a vascular approach using PICCline catheters'}, {'label': 'Midline group', 'description': 'Patients needing a vascular approach using Midline catheters'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anais CAILLARD', 'role': 'CONTACT', 'email': 'anais.caillard@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'AnaÏS CAILLARD', 'role': 'CONTACT', 'email': 'anais.caillard@chu-brest.fr', 'phone': '02 98 34 72 88'}, {'name': 'Brigitte HUIBAN', 'role': 'CONTACT', 'email': 'brigitte.huiban@chu-brest.fr'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning one year and ending five years following the publication', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}