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Search / Trial NCT06422533

Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients

Launched by INSTITUTO NACIONAL DE CANCEROLOGIA DE MEXICO · May 20, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ceftolozane/Tazobactam Piperacillin/Tazobactam Neutropenia Hematologic Neoplasms

ClinConnect Summary

This clinical trial is studying two different antibiotics, ceftolozane/tazobactam (C/T) and piperacillin/tazobactam (P/T), to see which one works better for treating blood infections (bacteremia) in patients with blood cancers and low white blood cell counts (severe neutropenia). These patients often have weakened immune systems due to chemotherapy, making them more vulnerable to infections. The trial aims to find out if C/T can provide a safer and more effective option, especially against certain tough bacteria that don't respond well to many treatments.

To join the study, participants need to be over 18 years old, have a diagnosis of a blood cancer, and show signs of fever and low white blood cell counts. They should also be stable enough to participate and expect to live for at least five more days. If selected, participants will receive one of the two antibiotics and will be monitored closely for their response to treatment. This research is important as it could help improve the care of patients facing serious infections during their cancer treatment.

Gender

ALL

Eligibility 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

About Instituto Nacional De Cancerologia De Mexico

The Instituto Nacional de Cancerología de México (INCan) is a premier national institution dedicated to cancer research, treatment, and prevention in Mexico. As a leading clinical trial sponsor, INCan plays a vital role in advancing oncological knowledge and therapeutic options through rigorous scientific investigation and collaboration with national and international research entities. The institute is committed to improving cancer care by conducting innovative clinical trials that adhere to the highest ethical standards, ensuring patient safety and the generation of valuable clinical data that contribute to the global fight against cancer.

Locations

Mexico City, Tlalpan, Mexico

Patients applied

0 patients applied

Trial Officials

Patricia Cornejo-Juarez, M.D.,M.Sc.

Principal Investigator

Instituto Nacional de Cancerología, Mexico

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported