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Dallas, Texas 75390


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.


Study summary:

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


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.


NCT ID:

NCT00625703


Primary Contact:

Principal Investigator
Jane Siegel, MD
University of Texas Southwestern Medical Center at Dallas

Jane Siegel, MD.
Phone: 214-648-3720
Email: jane.siegel@utsouthwestern.edu


Backup Contact:

Email: chonnamet.techasaensiri@utsouthwestern.edu
Chonnamet Techasaensiri, MD
Phone: 214-648-3720


Location Contact:

Dallas, Texas 75390
United States

Jane Siegel, MD
Phone: 214-648-3720
Email: jane.siegel@utsouthwestern.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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