Expired Study
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Los Angeles, California 90089


Purpose:

The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.


Study summary:

Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.


Criteria:

Inclusion Criteria: - Diagnosis of CF based on positive sweat chloride or known CF mutation - Age > 17 years - Able to spontaneously expectorate sputum Exclusion Criteria: - Any clinically significant laboratory abnormalities - Presence of an ongoing acute pulmonary exacerbation - Pregnancy - Serious past allergy to linezolid or tedizolid - No alcohol, nicotine, or caffeine-containing products during the study period


Study is Available At:


Original ID:

HS-15-00182


NCT ID:

NCT02444234


Secondary ID:


Study Acronym:


Brief Title:

Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis


Official Title:

Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Southern California


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Study Dates

Start Date:July 2015
Completion Date:December 31, 2017
Completion Type:Actual
Primary Completion Date:December 31, 2017
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 15, 2019
First Received Date:May 6, 2015
First Results Date:April 25, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Peak Plasma Concentration (Cmax)
Time Frame:2 days
Safety Issues:False
Description:Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome Type:Primary Outcome
Measure:Area Under the Plasma Concentration Versus Time Curve (AUC)
Time Frame:2 days
Safety Issues:False
Description:Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose*F/CL
Outcome Type:Primary Outcome
Measure:Time to Peak Plasma Concentration (Tmax)
Time Frame:2 days
Safety Issues:False
Description:Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome Type:Primary Outcome
Measure:Peak Sputum Concentration
Time Frame:2 days
Safety Issues:False
Description:Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome Type:Primary Outcome
Measure:Area Under the Sputum Concentration Versus Time Curve (AUC)
Time Frame:2 days
Safety Issues:False
Description:AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
Outcome Type:Primary Outcome
Measure:Time to Peak Sputum Concentration (Tmax)
Time Frame:2 days
Safety Issues:False
Description:Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

Study Interventions

Intervention Type:Drug
Name:Tedizolid PO
Description:Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
Arm Name:Tedizolid PO
Intervention Type:Drug
Name:Tedizolid IV
Description:Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
Arm Name:Tedizolid IV

Study Arms

Study Arm Type:Experimental
Arm Name:Tedizolid PO
Description:Tedizolid phophate 200mg tablet
Study Arm Type:Experimental
Arm Name:Tedizolid IV
Description:Tedizolid phophate 200mg IV

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Southern California
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck Sharp & Dohme Corp.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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