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Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Linezolid

About this trial

This is an interventional other trial for Cystic Fibrosis focused on measuring Pharmacokinetic

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Texas Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00625703

First Posted

February 19, 2008

Last Updated

March 13, 2020

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Cystic Fibrosis Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00625703

Brief Title

Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

Official Title

Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

Cystic Fibrosis Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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 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 cystic fibrosis transmembrane conductance regulator (CFTR) mutation on clearance of linezolid and for relationship between levels of linezolid achieved in sputum and blood and clinical outcome

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Pharmacokinetic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Linezolid

Other Intervention Name(s)

Zyvox

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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 Measure Information:

Title

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

Description

Time Frame

2 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Siegel, MD

Organizational Affiliation

University of Texas, Southwestern Medical Center at Dallas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of Linezolid in Children With Cystic Fibrosis

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