Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT00625703
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irb@utsouthwestern.edu', 'phone': '214-648-3111', 'title': 'Lus Stella Muniz, MD', 'organization': 'University of Texas Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful.'}}, 'adverseEventsModule': {'description': 'No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful', 'eventGroups': [{'id': 'EG000', 'title': 'Linezolid: Pharmacokinetics', 'description': "daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.", 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'No Data Available', 'notes': 'No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}], 'seriousEvents': [{'term': 'Data not available', 'notes': 'No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine the Pharmacokinetic Profile of IV (Intravenous) and PO (Oral) Formulations of Linezolid Among Children With Cystic Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid: Pharmacokinetics', 'description': "daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid."}], 'timeFrame': '2 months', 'description': 'To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful'}, {'type': 'SECONDARY', 'title': 'Pulmonary Exacerbations With Methicillin Resistant Staphylococcus Aureus (MRSA) to Treatment With Linezolid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid: Pharmacokinetics', 'description': "daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid."}], 'timeFrame': '2 months', 'description': "to characterize the clinical response of children with pulmonary exacerbations (increase in the severity of the patient's lung symptoms) associated with methicillin resistant Staphylococcus aureus (MRSA) to treatment with linezolid", 'reportingStatus': 'POSTED', 'populationDescription': 'No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linezolid: Pharmacokinetics', 'description': "daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No data available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful. Enrollment reflects the anticipated enrollment and actual enrollment is unknown due to PI is no longer at the institution.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Linezolid: Pharmacokinetics', 'description': "daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'participants', 'populationDescription': 'No data available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful. Enrollment reflects the anticipated enrollment and actual enrollment is unknown due to PI is no longer at the institution.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2008-02-19', 'resultsFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-13', 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Pharmacokinetic Profile of IV (Intravenous) and PO (Oral) Formulations of Linezolid Among Children With Cystic Fibrosis', 'timeFrame': '2 months', 'description': 'To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Exacerbations With Methicillin Resistant Staphylococcus Aureus (MRSA) to Treatment With Linezolid', 'timeFrame': '2 months', 'description': "to characterize the clinical response of children with pulmonary exacerbations (increase in the severity of the patient's lung symptoms) associated with methicillin resistant Staphylococcus aureus (MRSA) to treatment with linezolid"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetic'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.', 'detailedDescription': 'Patients with cystic fibrosis who have pulmonary exacerbations associated with the isolation of Methicillin-resistant Staphylococcus aureus (MRSA) in their sputum will be identified by their primary physicians and by laboratory record review. If they meet the inclusion criteria, they will be invited to participate in the study. The primary outcome variables include pharmacokinetic and pharmacodynamic indices. The study end points include completion of the sputum and blood sampling for pharmacokinetic studies of both intravenous and oral formulations of linezolid and collection of microbiologic specimen (sputum and anterior nares cultures) one month after discharge. Additionally, pharmacokinetic data will be analyzed for effects of age and cystic fibrosis transmembrane conductance regulator (CFTR) mutation on clearance of linezolid and for relationship between levels of linezolid achieved in sputum and blood and clinical outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects \\< 18 years of age inclusive, with a confirmed diagnosis of cystic fibrosis being admitted to the hospital for acute pulmonary exacerbation with MRSA isolated from sputum culture.\n* Female subject of childbearing potential must have a negative pregnancy test prior to the first dose of study drug, and if sexually active agrees to use an acceptable method of birth control per investigator judgment for the duration of the study.\n* Subjects who are receiving medications with serotonergic (such as certain types of antidepressants) and adrenergic activity that can not be discontinued based on clinical judgment of the primary physician may be enrolled. These subjects will be monitored closely for serotonin- and sympathomimetic-associated toxicity.\n* Subject (when able) and subject's parent /legal guardian agree to comply with the study requirements.\n* Subject has sufficient venous access to permit administration of the study medication, collection of pharmacokinetic samples and monitoring of safety variables.\n* Duration of linezolid therapy is expected to exceed 7 days.\n* English and Spanish-speaking subjects.\n\nExclusion Criteria:\n\n* Subjects with clinical or laboratory evidence of severe hepatic (Child-Pugh class C) disease\n* Subjects with severe renal impairment (estimated creatinine clearance \\<30 mL/min)\n* Subjects with a history of allergy to linezolid.\n* Pregnant and breastfeeding subjects."}, 'identificationModule': {'nctId': 'NCT00625703', 'briefTitle': 'Pharmacokinetics of Linezolid in Children With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Pharmacokinetics of Linezolid in Children With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'IRB File # 112007-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox'], 'description': "Pharmacokinetics\n\ndaily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.", 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Jane Siegel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, Southwestern Medical Center at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}