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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


Outcome Timeframe Day 60

NCTID NCT04673175

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2022-07-20

Completion Date 2025-12-31

Enrollment Target 20

Interventions

DRUG Ceftolozane / Tazobactam Injection

Locations Recruiting

Weill Cornell Medicine

United States, New York, New York


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