Recruiting

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

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What is being tested

Ceftolozane/tazobactam

+ Piperacillin/tazobactam

Drug
Who is being recruted

Cytopenia+7

+ Agranulocytosis

+ Hematologic Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorInstituto Nacional de Cancerologia de Mexico
Study ContactDiana Vilar Compte, M.D.,M.Sc.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 7, 2023

Actual date on which the first participant was enrolled.

This clinical trial aims to determine if two antibiotics, ceftolozane/tazobactam (C/T) and piperacillin/tazobactam (P/T), work equally well in treating serious infections caused by specific bacteria in patients with blood cancers who have a very low number of white blood cells and a fever. These patients are often at risk of getting infections from bacteria that are resistant to many drugs. Using C/T, an antibiotic approved for other serious infections, could help reduce the need for other powerful antibiotics that might contribute to resistance. This study is important because it could provide a new option for treating infections in these vulnerable patients, potentially improving their outcomes and managing antibiotic resistance better. Participants in this study will be randomly assigned to receive either the C/T or P/T antibiotic treatment. Medical staff will take blood samples to check for bacterial infections before starting the treatment. The response to the treatment will be assessed by checking if the participants survive, if their fever goes away, and if the bacteria are cleared from their blood within three to four days. Treatment will continue for at least five to seven days, depending on the bacteria found. If the initial treatment doesn’t work or if the patient's condition worsens, doctors will consider changing the treatment. Participants will be monitored closely for any side effects like diarrhea and will be followed up for 30 days after starting the treatment to ensure their health status is recorded accurately.

Official TitleCeftolozane/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
NCT06422533
Principal SponsorInstituto Nacional de Cancerologia de Mexico
Study ContactDiana Vilar Compte, M.D.,M.Sc.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

226 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAgranulocytosisHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersLeukopeniaNeoplasmsNeoplasms by SiteNeutropeniaHematologic Neoplasms

Criteria

7 inclusion criteria required to participate
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)

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5 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Ceftozolane/tazobactam (C/T) is a combination antibiotic with a new cephalosporin, structurally similar to ceftazidime, plus tazobactam. The FDA approved This known beta-lactamase inhibitor in 2018 to treat intra-abdominal and complicated urinary infections. In 2019, its indication was expanded to nosocomial pneumonia and those associated with mechanical ventilation. In Mexico, it was approved for marketing in June 2019. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteria and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens.

Group II

Active Comparator
At our hospital, Piperacillin/tazobactam is the primary drug used as an empirical treatment in patients with severe neutropenia and fever, according to Clinical Practice Guidelines for the use of antimicrobial agents in neutropenic patients with cancer.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Instituto Nacional de Cancerologia

Mexico City, MexicoOpen Instituto Nacional de Cancerologia in Google Maps
Recruiting
One Study Center