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CompletedNCT02444234Updated Jun 2, 2020Results posted

Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

A Phase 4 interventional study of Tedizolid PO and Tedizolid IV in Cystic Fibrosis, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-02.

Sponsored by University of Southern California · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Cystic Fibrosis
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 11 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of CF based on positive sweat chloride or known CF mutation
  • Age > 17 years
  • Able to spontaneously expectorate sputum

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Tedizolid PO

    Tedizolid phophate 200mg tablet

    Drug: Tedizolid PO

  • Experimental
    Tedizolid IV

    Tedizolid phophate 200mg IV

    Drug: Tedizolid IV

Interventions

  • DrugTedizolid PO

    Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.

  • DrugTedizolid IV

    Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

    Time frame: 2 days

  2. Area Under the Plasma Concentration Versus Time Curve (AUC)

    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

    Time frame: 2 days

  3. Time to Peak Plasma Concentration (Tmax)

    Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

    Time frame: 2 days

  4. Peak Sputum Concentration

    Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.

    Time frame: 2 days

  5. Area Under the Sputum Concentration Versus Time Curve (AUC)

    AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

    Time frame: 2 days

  6. Time to Peak Sputum Concentration (Tmax)

    Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.

    Time frame: 2 days

07

Results

Posted Jun 4, 2019
Limitations and caveats
Observed a large interindividual variability in the absorption rate constant. Due to difficulty of producing sputum, sputum samples were sparse. Did not include a control population to directly compare the pharmacokinetics in CF patients.

Participant flow

First Intervention (3 Days)
Participant flow — First Intervention (3 Days)
MilestoneTedizolid PO/IVTedizolid IV/PO
Started65
Completed65
Not completed00
Washout (2 Day Minimum)
Participant flow — Washout (2 Day Minimum)
MilestoneTedizolid PO/IVTedizolid IV/PO
Started65
Completed65
Not completed00
Second Intervention (3 Days)
Participant flow — Second Intervention (3 Days)
MilestoneTedizolid PO/IVTedizolid IV/PO
Started65
Completed65
Not completed00

Outcome measures

PrimaryPeak Plasma Concentration (Cmax)

Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

Time frame:
2 days
Reported as:
Mean · mg/liter
Peak Plasma Concentration (Cmax)
mg/literTedizolid POTedizolid IV
Peak Plasma Concentration (Cmax)2.22 ± 0.7452.92 ± .624
PrimaryArea Under the Plasma Concentration Versus Time Curve (AUC)

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

Time frame:
2 days
Reported as:
Mean · mg*h/mL
Area Under the Plasma Concentration Versus Time Curve (AUC)
mg*h/mLTedizolid POTedizolid IV
Area Under the Plasma Concentration Versus Time Curve (AUC)22.1 ± 5.7220.7 ± 3.92
PrimaryTime to Peak Plasma Concentration (Tmax)

Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

Time frame:
2 days
Reported as:
Mean · hours
Time to Peak Plasma Concentration (Tmax)
hoursTedizolid POTedizolid IV
Time to Peak Plasma Concentration (Tmax)2.5 ± 1.331.36 ± 0.369
PrimaryPeak Sputum Concentration

Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.

Time frame:
2 days
Reported as:
Mean · mg/liter
Peak Sputum Concentration
mg/literTedizolid POTedizolid IV
Peak Sputum Concentration1.08 ± 0.61.196 ± 0
PrimaryArea Under the Sputum Concentration Versus Time Curve (AUC)

AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

Time frame:
2 days
Reported as:
Mean · mg*h/mL
Area Under the Sputum Concentration Versus Time Curve (AUC)
mg*h/mLTedizolid POTedizolid IV
Area Under the Sputum Concentration Versus Time Curve (AUC)15.04 ± 8.9213.53 ± 7.203
PrimaryTime to Peak Sputum Concentration (Tmax)

Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.

Time frame:
2 days
Reported as:
Mean · hours
Time to Peak Sputum Concentration (Tmax)
hoursTedizolid POTedizolid IV
Time to Peak Sputum Concentration (Tmax)4 ± 03 ± 0

Adverse events

Collected over 10 days. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tedizolid PO0/11 (0%)0/11 (0%)1/11 (9.1%)
Tedizolid IV0/11 (0%)0/11 (0%)1/11 (9.1%)
Most frequent other events
Most frequent other events
EventTedizolid POTedizolid IV
DiarrheaGeneral disorders1/111/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Study Participants
Mean27.27 ± 4.78
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female5
Male6
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Study Participants
Hispanic or Latino3
Not Hispanic or Latino8
Unknown or Not Reported0
Creatinine Clearance
Creatinine Clearance(mL/min)All Study Participants
Mean147.6 ± 32.43
Body Mass Index
Body Mass Index(kg/m2)All Study Participants
Mean21.72 ± 3.60
08

Study locations

1 site
  • University of Southern California
    Los Angeles, California 90089, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 26, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02444234
Lead sponsor
University of Southern California
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Paul Beringer (Associate Professor, University of Southern California) — Principal investigator
First posted
May 14, 2015
Start date
Jul 2015
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Results posted
Jun 4, 2019
Last update
Jun 2, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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