Telavancin Pharmacokinetics in Cystic Fibrosis Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

Each participant will receive 3 doses of intravenous telavancin administered every 24 hours. Up to three different doses of telavancin will be studied (n=6 per group). Blood samples will be collected throughout the study to determine the pharmacokinetics of telavancin. Each group will proceed after measurement of safety, tolerability, and pharmacokinetics of the lower dose group before it. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03172793
Study type	Interventional
Source	Hartford Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	August 8, 2017
Completion date	April 17, 2019

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