Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation

• Status: Suspended
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ceftolozane; Ceftolozane, tazobactam drug combination; Tazobactam

Criteria

Inclusion Criteria:

• At least 18 years old

• Presence of hematologic malignancy or Hematopoietic Stem Cell Transplantation

Exclusion Criteria:

• Under the age of 18 years old

• Anaphylactic hypersensitivity or allergic reaction to cephalosporins

• Participants with expected mortality within 48 hours

• Hemodialysis or continuous renal replacement therapy