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NCT03172793 · ClinicalTrials.gov registry record · Phase 4
Telavancin Pharmacokinetics in Cystic Fibrosis Patients
A Phase 4 study of Cystic Fibrosis, sponsored by Joseph L. Kuti, PharmD.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 5
- Study locations
NCT03172793: Completed Phase 4 study of Cystic Fibrosis, sponsored by Joseph L. Kuti, PharmD.
NCT03172793 is a Phase 4 study of Cystic Fibrosis that has completed, run by Joseph L. Kuti, PharmD. The registered enrollment target is 18 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03172793, a Phase 4 study of Cystic Fibrosis, has completed, sponsored by Joseph L. Kuti, PharmD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 5
- Study locations
Study Summary
Due to emerging resistance, new antibiotic options are needed to treat CF acute pulmonary exacerbations caused by methicillin resistant Staphylococcus aureus (MRSA). There is established evidence that adult patients with cystic fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Telavancin is a lipoglycopeptide antibiotic that has activity against gram-positive bacteria including MRSA. This study will determine the pharmacokinetics and tolerability of telavancin in 18 adult CF patients admitted for a pulmonary exacerbation at 1 of 4 participating hospitals in the US.
Primary Outcome
This outcome measures the total body clearance (L/hr) of telavancin over the 4 day study.
Conditions Studied
Interventions
- DRUG Telavancin Injection
Study Locations (5)
Indiana
- IU Health University Hospital - Indianapolis
- Riley Hospital for Children - Indianapolis
Pennsylvania
- St. Christophers Hospital for Children - Philadelphia
- University of Pittsburgh Medical Center Shadyside - Pittsburgh
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2019-04-17 |
| Phase | Phase 4 |
What the finished NCT03172793 record still lists
NCT03172793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Telavancin Injection is the first listed.
NCT03172793 lists 5 locations in 3 states (Indiana, Pennsylvania, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03172793 about?
NCT03172793 is a clinical study titled "Telavancin Pharmacokinetics in Cystic Fibrosis Patients". Due to emerging resistance, new antibiotic options are needed to treat CF acute pulmonary exacerbations caused by methicillin resistant Staphylococcus aureus (MRSA). There is established evidence that adult patients with cystic fibrosis (CF) may have altered antibiotic pharmacokinetics compared with...
What is the current status of trial NCT03172793?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2017-08-08. Estimated completion is 2019-04-17.
What conditions does trial NCT03172793 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03172793?
The interventions under investigation include: Telavancin Injection (DRUG).
Who is sponsoring clinical trial NCT03172793?
This trial is sponsored by Joseph L. Kuti, PharmD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03172793 being conducted?
This trial has 5 study locations across Connecticut, Indiana, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03172793's enrollment target sits among peer trials
18 135th of 169 higher than 33 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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