Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02421120 · ClinicalTrials.gov registry record · Phase 4
Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
A Phase 4 study, sponsored by Joseph L. Kuti, PharmD.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT02421120 is a Phase 4 study that has completed, run by Joseph L. Kuti, PharmD. The registered enrollment target is 21 participants.
The verdict
NCT02421120, a Phase 4 study, has completed, sponsored by Joseph L. Kuti, PharmD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly approved broad spectrum intravenous antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day study.
Interventions
- DRUG Ceftolozane/Tazobactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02421120
The ClinicalTrials.gov registry entry for NCT02421120 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph L. Kuti, PharmD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ceftolozane/Tazobactam is the first listed.
NCT02421120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02421120 about?
NCT02421120 is a clinical study titled "Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients". There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly approved broad spectrum intravenous antibiotic, which has potent in vitro activity against multidrug resistant Pse...
What is the current status of trial NCT02421120?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2015-09. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02421120?
The interventions under investigation include: Ceftolozane/Tazobactam (DRUG).
Who is sponsoring clinical trial NCT02421120?
This trial is sponsored by Joseph L. Kuti, PharmD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.