Using Ceftolozane-Tazobactam to Treat Pseudomonas Aeruginosa Infections in Cancer Patients
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
This study is testing if a specific antibiotic can help cancer patients with serious infections caused by a tough bacteria called Pseudomonas aeruginosa.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04673175 on ClinicalTrials.gov |
What this trial studies
This open-label clinical trial evaluates the effectiveness of ceftolozane-tazobactam as a primary treatment for infections caused by Pseudomonas aeruginosa in patients with hematological malignancies or those who have undergone hematopoietic stem cell transplantation. Participants will receive the medication and be monitored for approximately 60 days to assess treatment outcomes. The study aims to determine if this FDA-approved antibiotic can effectively combat serious bacterial infections in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with hematologic malignancies or those who have undergone hematopoietic stem cell transplantation and have confirmed Pseudomonas aeruginosa infections.
Not a fit: Patients with severe allergic reactions to cephalosporins or those with expected mortality within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing severe Pseudomonas aeruginosa infections in patients with compromised immune systems.
How similar studies have performed: Other studies have shown promise in using ceftolozane-tazobactam for treating Pseudomonas aeruginosa infections, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Markus Plate, MD — Weill Medical College of Cornell University
- Study coordinator: Anna Gwak, BA
- Email: ang4021@med.cornell.edu
- Phone: 2127464089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.