Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

NCT00625703 | Completed Phase 2 Results

• 1 other identifier: IRB File # 112007-010
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• To Determine the Pharmacokinetic Profile of IV (Intravenous) and PO (Oral) Formulations of Linezolid Among Children With Cystic Fibrosis

  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.

  2 months

Secondary Outcomes (1)

• Pulmonary Exacerbations With Methicillin Resistant Staphylococcus Aureus (MRSA) to Treatment With Linezolid

  2 months

Study Arms (1)

A

EXPERIMENTAL

Drug: Linezolid

Interventions

Linezolid DRUG

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.

Also known as: Zyvox

A

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Lus Stella Muniz, MD
• Organization: University of Texas Southwestern Medical Center

irb@utsouthwestern.edu

214-648-3111

Study Officials

• Jane Siegel, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-03

Locations

US (1)