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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Dec 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called ceftolozane-tazobactam to treat infections caused by a bacteria known as Pseudomonas aeruginosa in patients who have certain types of blood cancers or have recently undergone a stem cell transplant. The trial is open-label, meaning both the doctors and the participants know that ceftolozane-tazobactam is the treatment being given. Researchers hope that this medication will be effective as a primary treatment for these serious infections. Participants will be monitored for about 60 days to see how well the treatment works.

To be eligible for this trial, participants need to be at least 18 years old and have a diagnosed blood cancer or have had a stem cell transplant, along with a confirmed Pseudomonas aeruginosa infection. However, those with severe allergies to similar medications, certain kidney issues, or those who have received other specific treatments for more than 72 hours would not qualify. It's important to note that if someone completes the trial and later develops another Pseudomonas aeruginosa infection, they may be able to join the study again if they meet the criteria.

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Eligibility criteria

• 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.