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A Pilot Study of Ceftolozane-Tazobactam in Conjunction With Rapid Molecular Diagnosis for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
Description
This is an open-label study, where participants will be given ceftolozane-tazobactam as the primary treatment for Pseudomonas aeruginosa infections. Open-label means both the investigator and the participant will known what drug will be given. Participants will be followed for approximately 60 days. Ceftolozane-tazobactam is approved by the Food and Drug Administration (FDA) for treatment of serious bacterial infection and the investigator hypothesizes that ceftolozane/tazobactam may be effective as the primary antibiotic treatment for Pseudomonas aeruginosa infections.
Trial Eligibility
Inclusion Criteria: * At least 18 years old * Presence of hematologic malignancy or Hematopoietic Stem Cell Transplantation * Identification of Pseudomonas aeruginosa by rapid molecular diagnostic assay from a blood culture or from a respiratory sample in the setting of radiologically documented pneumonia and clinical symptoms compatible with pneumonia. Exclusion Criteria: * Anaphylactic hypersensitivity or allergic reaction to cephalosporins * Participants with expected mortality within 48 hours * Hemodialysis or continuous renal replacement therapy, or creatinine clearance \<15 ml/min * Prior non-study anti-pseudomonal therapy for \>72 hours * History of a strain of Pseudomonas aeruginosa with MIC \>4 microgram/ml to ceftolozane/tazobactam * Polymicrobial aerobic Gram-negative infection as determined by ID research team Patients who completed this study and subsequently experience a separate, recurrent Pseudomonas aeruginosa infection, may be re-enrolled into this study if all eligibility criteria are met.
Study Info
Organization
Weill Medical College of Cornell University
Primary Outcome
Global response at end of therapy
Interventions
Locations Recruiting
Weill Cornell Medicine
United States, New York, New York
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