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
Ceftolozane/tazobactam
+ Piperacillin/tazobactam
Cytopenia+7
+ Agranulocytosis
+ Hematologic Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.226 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Instituto Nacional de Cancerologia
Mexico City, MexicoOpen Instituto Nacional de Cancerologia in Google Maps