Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-24 @ 6:22 PM
Study NCT ID:
NCT02081560
Status:
UNKNOWN
Last Update Posted:
2014-03-07
First Post:
2014-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colistin Pharmacokinetics in Continuous Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003091', 'term': 'Colistin'}], 'ancestors': [{'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-06', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC)', 'timeFrame': 'predose, and 0.5, 1, 2, 4, 6, 8 hours after administration'}], 'secondaryOutcomes': [{'measure': 'Sings of neurotoxicity and nephrotoxicity', 'timeFrame': 'Expected average of follow up is about 14 days.', 'description': 'Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support.'}, {'measure': 'Sings of neurotoxicity and nephrotoxicity', 'timeFrame': 'Expected average of follow up is about 14 days.', 'description': 'Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. The patients will be followed for the duration of colistin administration at the dose studied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'antibiotic', 'Gram negative', 'continuous renal replacement therapy'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '30478168', 'type': 'DERIVED', 'citation': 'Leuppi-Taegtmeyer AB, Decosterd L, Osthoff M, Mueller NJ, Buclin T, Corti N. Multicenter Population Pharmacokinetic Study of Colistimethate Sodium and Colistin Dosed as in Normal Renal Function in Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01957-18. doi: 10.1128/AAC.01957-18. Print 2019 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.\n\nHypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.', 'detailedDescription': 'After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.\n\nPatients are monitored for signs of neuro- and nephrotoxicity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female aged 18 years or older\n* hospitalised on the ICU\n* gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care\n* clinical necessity for continuous venovenous renal replacement therapy\n\nExclusion Criteria:\n\n* History of hypersensitivity to colistin or to other polymyxins\n* Personal or family history of Myasthenia Gravis'}, 'identificationModule': {'nctId': 'NCT02081560', 'briefTitle': 'Colistin Pharmacokinetics in Continuous Renal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)', 'orgStudyIdInfo': {'id': 'COLPKZH11'}, 'secondaryIdInfos': [{'id': '213DR11032', 'type': 'OTHER', 'domain': 'Swissmedic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'colistin pharmacokinetics', 'description': 'Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required', 'interventionNames': ['Drug: Colistin']}], 'interventions': [{'name': 'Colistin', 'type': 'DRUG', 'description': 'Colistin i.v. three times daily as long a necessary for infection treatment', 'armGroupLabels': ['colistin pharmacokinetics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Natascia Corti, MD', 'role': 'CONTACT', 'email': 'natascia.corti@usz.ch', 'phone': '041 (0) 44 255 20 78'}, {'name': 'Natascia Corti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Zurich, Dept. of Pharmacology and Toxicology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Natascia Corti, MD', 'role': 'CONTACT', 'email': 'natascia.corti@usz.ch', 'phone': '044 255 20 78'}], 'overallOfficials': [{'name': 'Natascia Corti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Dept. of Pharmacology and Toxicology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}