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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 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.

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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.

Conditions Studied

Cystic Fibrosis

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

FieldValue
Enrollment Target 18 participants
Start Date 2017-08-08
Est. Completion 2019-04-17
Phase Phase 4

Sponsor

Joseph L. Kuti, PharmD

4 total trials

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What the Registry Record Tells You About NCT03172793

The ClinicalTrials.gov registry entry for NCT03172793 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower). The listed sponsor is Joseph L. Kuti, PharmD, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.