drugset / Trial / NCT03172793

Telavancin Pharmacokinetics in Cystic Fibrosis Patients

NCT03172793

Non-randomizedSequentialOpen-labelOther

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.

Timeline

Start
2017-08-08
Primary completion
2019-04-17
Completion
2019-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Telavancin Other / unclassified 7.5 mg/kg Intravenous
Subject Telavancin Other / unclassified 10 mg/kg Intravenous
Subject Telavancin Other / unclassified 12.5 mg/kg Intravenous
Subject Telavancin Other / unclassified 15 mg/kg Intravenous

Indications