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Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625703
First Posted: February 28, 2008
Last Update Posted: January 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention Phase
Cystic Fibrosis Drug: Linezolid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2 months ]

Estimated Enrollment: 14
Study Start Date: May 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Linezolid

Pharmacokinetics

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.

Other Name: Zyvox

Detailed Description:
Patients with cystic fibrosis who have pulmonary exacerbations associated with the isolation of 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 CFTR mutation on clearance of linezolid and for relationship between levels of linezolid achieved in sputum and blood and clinical outcome
  Eligibility

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.
  • 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.
  • Subject (when able) and subject's parent /legal guardian agree to comply with the study requirements.
  • Subject has sufficient venous access to permit administration of the study medication, collection of pharmacokinetic samples and monitoring of safety variables.
  • Duration of linezolid therapy is expected to exceed 7 days.
  • English and Spanish-speaking subjects.

Exclusion Criteria:

  • Subjects with clinical or laboratory evidence of severe hepatic (Child-Pugh class C) disease
  • Subjects with severe renal impairment (estimated creatinine clearance <30 mL/min)
  • Subjects with a history of allergy to linezolid.
  • Pregnant and breastfeeding subjects.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625703


Contacts
Contact: Jane Siegel, MD. 214-648-3720 jane.siegel@utsouthwestern.edu
Contact: Chonnamet Techasaensiri, MD 214-648-3720 chonnamet.techasaensiri@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Jane Siegel, MD    214-648-3720    jane.siegel@utsouthwestern.edu   
Contact: Chonnamet Techasaensiri, MD    214-648-3720    chonnamet.techasensiri@utsouthwestern.edu   
Sub-Investigator: Roberto Santos, MD         
Sub-Investigator: Claude Prestidge, MD         
Sub-Investigator: Michael E Brown, MD         
Sub-Investigator: Chonnamet Techasaensiri, MD         
Sub-Investigator: Pablo J. Sanchez, MD         
Sub-Investigator: Steven Copenhaver, MD         
Sub-Investigator: Andrew Gelfand, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Cystic Fibrosis Foundation Therapeutics
Investigators
Principal Investigator: Jane Siegel, MD University of Texas, Southwestern Medical Center at Dallas
  More Information

Responsible Party: Jane Siegel, MD, University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00625703     History of Changes
Other Study ID Numbers: IRB File # 112007-010
First Submitted: February 19, 2008
First Posted: February 28, 2008
Last Update Posted: January 23, 2009
Last Verified: December 2008

Keywords provided by University of Texas Southwestern Medical Center:
Pharmacokinetic

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action