Comparing two antibiotics for treating blood infections in cancer patients
Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hemato-oncological Patients With Severe Neutropenia and Fever: Non-inferiority Study
This study tests whether a new antibiotic called ceftolozane/tazobactam works just as well as the standard antibiotic piperacillin/tazobactam for treating blood infections in cancer patients with low white blood cell counts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cancerologia de Mexico Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mexico City, Tlalpan) |
| Trial ID | NCT06422533 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of ceftolozane/tazobactam compared to piperacillin/tazobactam in treating bacteremia in patients with hematological malignancies who are experiencing severe neutropenia. The research aims to demonstrate that ceftolozane/tazobactam is non-inferior to piperacillin/tazobactam, particularly in cases involving multidrug-resistant Gram-negative bacteria. Patients will be monitored for clinical outcomes, and the study will focus on those with fever and bacteremia due to resistant strains. The goal is to provide a safer alternative to traditional antibiotics that may contribute to resistance issues.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with hematological malignancies, severe neutropenia, and fever.
Not a fit: Patients with known hypersensitivity to cephalosporins or those with severe hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with severe infections caused by resistant bacteria.
How similar studies have performed: Other studies have shown promising results using ceftolozane/tazobactam in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients \>18 years old * Diagnosis of any hematological malignancy * Severe neutropenia (polymorphonuclear \<500 cells/mm3) * Fever (≥38.3 degrees Celsius in one measure, or ≥38 degrees Celsius in at least two measures) * Median arterial pressure ≥65 mmHg on admission * A life expectancy ≥ 5 days * Agree to participate in the study Exclusion Criteria: * Known hypersensitivity to cephalosporins or anaphylaxis with beta-lactams * Clinical signs related to hemodynamic instability * Concomitant use of another antibiotic with activity against Gram-negatives (except Trimethoprim/Sulfamethoxazole (TMP/SMX) as prophylaxis for P. jirovecii * Patients with end-stage chronic renal failure (\<10 ml/min by creatinine clearance-ACCr) or on renal replacement therapy. * Patients with grade IV mucositis
Where this trial is running
Mexico City, Tlalpan
- Instituto Nacional de Cancerologia — Mexico City, Tlalpan, Mexico (Recruiting)
Study contacts
- Principal investigator: Patricia Cornejo-Juarez, M.D.,M.Sc. — Instituto Nacional de Cancerología, Mexico
- Study coordinator: Diana Vilar Compte, M.D.,M.Sc.
- Email: diana_vilar@yahoo.com.mx
- Phone: +52 5628 0400
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.