NCT03172793

Telavancin Pharmacokinetics in Cystic Fibrosis Patients

Pharmacokinetics and Tolerability of Telavancin at Differing Dosing Regimens in Cystic Fibrosis Adults Admitted With Acute Pulmonary Exacerbations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Joseph L. Kuti, PharmD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Telavancin Injection	Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.

Timeline

• Start date: 2017-08-08
• Primary completion: 2019-04-17
• Completion: 2019-04-17
• First posted: 2017-06-01
• Last updated: 2019-10-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study