Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Linezolid (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Jane Siegel, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center at Dallas
Overall contact:
Jane Siegel, MD., Phone: 214-648-3720, Email: jane.siegel@utsouthwestern.edu
Summary
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.
Clinical Details
Official title: Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
Study design: Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: 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.
Secondary outcome: 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
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
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Jane Siegel, MD., Phone: 214-648-3720, Email: jane.siegel@utsouthwestern.edu
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States; Recruiting
Jane Siegel, MD, Phone: 214-648-3720, Email: jane.siegel@utsouthwestern.edu
Chonnamet Techasaensiri, MD, Phone: 214-648-3720, Email: chonnamet.techasensiri@utsouthwestern.edu
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, Sub-Investigator
Additional Information
Starting date: May 2008
Ending date: July 2009
Last updated: January 21, 2009
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