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Telavancin Pharmacokinetics in Cystic Fibrosis Patients

NCT03172793 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-10-24

No results posted yet for this 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

Interventions

DRUG

Telavancin Injection

Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.

Sponsors & Collaborators

  • Cumberland Pharmaceuticals, Inc.

    collaborator UNKNOWN

  • Joseph L. Kuti, PharmD

    lead OTHER

Principal Investigators

  • Joseph L Kuti, PharmD · Hartford Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2019-04-17
Completion
2019-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172793 on ClinicalTrials.gov