Status:
COMPLETED
Pharmacokinetics of Linezolid in Children With Cystic Fibrosis
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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.
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00625703
Start Date
December 1 2010
End Date
May 1 2011
Last Update
March 27 2020
Active Locations (1)
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1
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390