Telavancin Pharmacokinetics in Cystic Fibrosis Patients

Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - Any
Start Date:August 8, 2017
End Date:June 30, 2019
Contact:Joseph L Kuti, PharmD

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

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.

Inclusion Criteria:

- Age 18 years or older

- Documented diagnosis of CF

- Acute pulmonary exacerbation as the primary reason for admission to the hospital with
requirement to receive systemic antibiotic treatment, as defined by treating provider

- If female, subjects must be non-pregnant and non-lactating. Females can be either not
of a child-bearing potential or if of a child-bearing potential, on acceptable modes
of birth control such as abstinence from sexual intercourse, oral/parenteral
contraceptives, or barrier method

Exclusion Criteria:

- History of any moderate or severe hypersensitivity or allergic reaction to telavancin
or any component of telavancin, or any glycopeptide (e.g., vancomycin) antibiotic (a
history of red man syndrome with vancomycin is not an exclusion criteria)

- History of any solid organ transplantation within the last 12 months

- Moderate to severe renal dysfunction defined as a creatinine clearance (CLCR) < 50
mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or
requirement for continuous renal replacement therapy or hemodialysis

- Oliguria (urine output < 0.4 mL/kg/hr for at least 12 hours, up to a total of <20
mL/hr) or significant alterations in fluid/electrolyte homeostasis in a 72 hour window
before enrollment with a history of renal compromise

- A hemoglobin less than 8 gm/dl at baseline

- Anticipated length of hospital stay less than 4 days, which would prevent completion
of dose administration and pharmacokinetic sampling

- Receiving intravenous vancomycin at the time of enrollment or anticipation of
requiring intravenous vancomycin during study participation (Note. Other antibiotics
targeting Gram-positive bacteria such as MRSA are permitted)

- Receiving an anticoagulant AND requires specific coagulation testing (prothrombin
time/international normalized ratio, activated partial thromboplastin time, activated
clotting time, or coagulation based factor x activity assay) within 24 hours of
receiving a telavancin dose (Note. Although telavancin does not interfere with
coagulation, it may interfere with some assays used to monitor coagulation)

- Requirement of concomitant administration of agents containing a cyclodextrin
solubilizer such as intravenous voriconazole or itraconazole

- Any rapidly-progressing disease or immediately life-threatening illness (defined as
imminent death within 48 hours in the opinion of the investigator)

- Any condition or circumstance that, in the opinion of the investigator, would
compromise the safety of the patient or the quality of study data

- Planned or prior participation in any other interventional drug study within 30 days
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