Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered
antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly
approved broad spectrum intravenous antibiotic, which has potent in vitro activity against
multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF
pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of
ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one
of 4 participating hospitals in the US. Patients will remain on standard of care IV
antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will
be sampled after the final dose to determine concentrations and pharmacokinetics of
ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day
study.
Phase:
Phase 4
Details
Lead Sponsor:
Joseph Kuti Joseph L. Kuti, PharmD
Collaborators:
Cubist Pharmaceuticals LLC Indiana University Health Riley Hospital for Chilren at Indiana University Health St. Christopher's Hospital for Children University of North Carolina
Treatments:
Ceftolozane Ceftolozane, tazobactam drug combination Cephalosporins Penicillanic Acid Tazobactam