Status:
TERMINATED
Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Pseudomonas Aeruginosa
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 part...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04673175
Start Date
July 20 2022
End Date
March 16 2025
Last Update
July 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medicine
New York, New York, United States, 10065