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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: Completed Phase 4 study, sponsored by Joseph L. Kuti, PharmD.
NCT02421120 is a Phase 4 study that has completed, run by Joseph L. Kuti, PharmD. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome determines the clearance of ceftolozane over the 8 hour dosing interval.
Interventions
- DRUG Ceftolozane/Tazobactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
What the finished NCT02421120 record still lists
NCT02421120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Ceftolozane/Tazobactam is the first listed.
NCT02421120 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02421120's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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