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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.
Hartford Hospital
Hartford, Connecticut, United States
IU Health University Hospital
Indianapolis, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
St. Christophers Hospital for Children
Philadelphia, Pennsylvania, United States
Telavancin Clearance
This outcome measures the total body clearance (L/hr) of telavancin over the 4 day study.
Time frame: 1, 24, 25, 48, 49-49.08, 49.25-49.5, 50-51, 52-53, 55-56, 57-61, and 72 hours after start of dosing.
Telavancin Volume of Distribution
This outcome measures the volume of distribution (L) of telavancin over the 4 day study.
Time frame: 1, 24, 25, 48, 49-49.08, 49.25-49.5, 50-51, 52-53, 55-56, 57-61, and 72 hours after start of dosing.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
This outcome measures the safety and tolerability of telavancin over the 4 day study with specific attention to changes in chemistry, complete blood count, and liver function tests before and after treatment, as well as any participant reported adverse events.
Time frame: 4 days
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University of Pittsburgh Medical Center Shadyside
Pittsburgh, Pennsylvania, United States