Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-06 @ 12:26 PM
Study NCT ID:
NCT03246360
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2017-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The equivalence of the Pharmacokinetic-Pharmacodynamic indicators commonly used for the study of betalactamines: T> minimal inhibitory concentration', 'timeFrame': 'Six days'}, {'measure': 'The equivalence of the Pharmacokinetic-Pharmacodynamic indicators commonly used for the study of betalactamines: the area under the curve (AUC) / minimal inhibitory concentration', 'timeFrame': 'Six days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection', 'Methicillin Susceptible Staphylococcus Aureus Infection', 'Cloxacillin Treatment']}, 'descriptionModule': {'briefSummary': 'Our objective is to establish pharmacological equivalence of intermittent and continuous infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and joint infections (BJI). Twelve patients suffering MSSA BJI will receive both administration modalities and serum concentrations of cloxacillin will be determined after 3 days of II and 3 days of continuous infusion in a prospective, randomized, open-label, monocentric crossover study design.', 'detailedDescription': 'Introduction Staphylococcus aureus is the main causative agent of bone and joint infections (BJI). More than 80% of the strains isolated in France are methicillin-susceptible (MSSA). During the early phase of MSSA BJI management national and international guidelines recommend the use of intra-venous type M penicillin with a dosage ranging from 100 to 200 mg/kg/day. Pharmacological properties of this class of penicillin require 4 to 6 infusions by day. Continuous infusion of beta-lactams is increasingly used especially in intensive care units. It allows an improvement of pharmacokinetic/pharmacodynamics (PK/PD) parameters and a reduction in time dedicated to infusion preparations by the nurses. However pharmacological data regarding such administration is required for type M penicillin.\n\nDesign A 6-day, prospective, randomized, open-label, monocentric crossover study\n\nParticipants Twelve adult patients with MSSA BJI\n\nIntervention Patients will be randomized in two groups: the first group will receive 3 days of cloxacillin (150 mg/kg/day) through 4 intermittent infusions/day followed by 3 days of cloxacillin (150 mg/kg/day) through continuous infusion (2 infusions during 12 hours). In the second group the infusion modalities will be inverted and continuous infusion will be preceded by a loading dose. Serum concentrations of cloxacillin will be determined at Day 3 and Days 6 The area under the curve / minimal inhibitory concentration ratio will be use to establish the equivalence between both administration modalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Staphylococcus aureus sensitive to methicillin and to be treated with cloxacillin by injectable antibiotic monotherapy For patients with Osteo-articular infection on material\n\n * Presence of a fistula in contact with the prosthesis or implant.\n * Pus in the joint or in contact with the prosthesis or implant\n * Presence of at least 1 positive sample (1 sampling by articular puncture or 1 peroperative sampling or by blood culture)\n * A histological analysis of the peri-prosthetic osteo-articular tissue which is the object of acute inflammation is a strong argument in favor of an Osteo-articular infection on material\n\nFor spondylodiscitis\n\n* Culture of a disco-vertebral biopsy puncture to isolate a methicillin sensitive S. aureus\n* Positive haemocultures for S. aureus sensitive to methicillin with imaging examination (CT or MRI of the spine) showing images of spondylodiscitis\n\nFor primitive arthritis :\n\n* Culture of a positive methicillin-sensitive S. aureus articular fluid puncture\n* Cultivation of a methicillin-sensitive S. aureus-positive surgical joint lavage fluid\n\nFor osteitis the diagnosis is based on the following criterion:\n\n\\*Culture of surgical specimens from a focal zone of methicillin-sensitive S. aureus-positive osteitis\n\nExclusion Criteria:\n\n* Allergy to betalactamines\n* Taking penicillin M within 36 hours before inclusion Renal function impaired with a glomerular filtration rate measured by MDRD formula of less than 30 ml / min\n* Patient with renal function expected to change within 6 days of inclusion\n* Hepatocellular insufficiency, whatever the degree\n\n -\\*Methotrexate intake\n* Polytransfused (more than 2 CGR) in the previous week\n* Patients requiring resuscitation'}, 'identificationModule': {'nctId': 'NCT03246360', 'acronym': 'CLOXA Continue', 'briefTitle': 'Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin During Bone and Joint Infections: a Prospective, Randomized, Open-label, Monocentric Crossover Study.', 'orgStudyIdInfo': {'id': '16-PP-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent administration of cloxacillin', 'interventionNames': ['Drug: Modification for administration mode of cloxacillin antibiotic']}, {'type': 'EXPERIMENTAL', 'label': 'continuous administration of cloxacillin', 'interventionNames': ['Drug: Modification for administration mode of cloxacillin antibiotic']}], 'interventions': [{'name': 'Modification for administration mode of cloxacillin antibiotic', 'type': 'DRUG', 'description': 'For intermittent administration, patients will benefit from cloxacillin treatment in conventional hospitalization, in accordance with national guidelines, at a dose of 150 mg / kg per day in 4 infusions, not exceeding the maximum daily dose of 12 g / day according to.\n\nFor continuous administration the same quantity of cloxacillin 150 mg / kg per day, without exceeding the maximum daily dose of 12 g / day, will be delivered by a self-propelled syringe in twice 12 hours. Patients randomly assigned to receive continuous administration will receive a dose of cloxacillin equivalent to the dose administered 4 times daily during iterative administration using a self-pulsating syringe. For the first day of the study, this loading dose will be subtracted from the 150 mg / kg dose to be administered continuously over the remaining 23 hours of the first day of the study and never exceed 12g / day.\n\nPharmacological dosages will be performed on the third and sixth day in both arms', 'armGroupLabels': ['Intermittent administration of cloxacillin', 'continuous administration of cloxacillin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Johan Johan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}