Phase 4
Completed N=11
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Source: ClinicalTrials.gov NCT02444234 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Peak Plasma Concentration (Cmax) — 2.22; 2.92 mg/liter
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration (Cmax) |
2.22; 2.92 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) |
22.1; 20.7 | — |
| PRIMARY Time to Peak Plasma Concentration (Tmax) |
2.5; 1.36 | — |
| PRIMARY Peak Sputum Concentration |
1.08; 1.196 | — |
| PRIMARY Area Under the Sputum Concentration Versus Time Curve (AUC) |
15.04; 13.53 | — |
| PRIMARY Time to Peak Sputum Concentration (Tmax) |
4; 3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02444234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.