Carbapenem-Sparing Strategies for ESBL Producers: When and How.
Ilias Karaiskos, Helen Giamarellou
https://pubmed.ncbi.nlm.nih.gov/32033322Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06422533
Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for Treating Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hematologic Cancer Patients With Severe Neutropenia and Fever
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2024-06-04
226
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with hematological malignancies who undergo highly myelotoxic chemotherapy, leading to severe neutropenia and fever, putting them at high risk for bacteremia caused by multidrug-resistant (MDR) Gram-negative bacteria such as Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR Pseudomonas aeruginosa. The study aims to compare the clinical and microbiological responses between two antibiotic treatments, ceftolozane/tazobactam (C/T) and piperacillin/tazobactam (P/T), to evaluate if C/T can reduce carbapenem use in this vulnerable group. Participants are randomly assigned to receive either C/T or P/T, with C/T administered as a 1.5 g intravenous infusion three times daily over one hour for 5 to 7 days, and P/T given as a 4.5 g intravenous infusion four times daily over 30 minutes for the same duration. Treatment begins after confirming severe neutropenia and fever, with blood cultures taken before antibiotic administration. Patients are monitored closely, and if fever persists or bacteria are resistant, therapy may be adjusted. The study excludes those with certain allergies, severe kidney failure, or concurrent antibiotic use except specific prophylaxis. During the study, patients are evaluated daily until fever resolves and hospital discharge, including follow-up until 30 days post-enrollment. Researchers assess survival, fever resolution, blood culture sterilization within 72 to 96 hours, and clinical response. Safety monitoring includes tracking adverse events and infections like Clostridiodes difficile. The primary outcome is mortality at 30 days, with secondary outcomes measuring microbiological and clinical responses. The study lasts through hospital stay and follow-up calls if discharged early.
CONDITIONS
Brief Title
Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Diagnosis of any hematological malignancy
- Severe neutropenia (polymorphonuclear cells less than 500 cells/mm3)
- Fever of at least 38.3 degrees Celsius in one measurement or 38 degrees Celsius in two measurements
- Median arterial pressure of 65 mmHg or higher on admission
- Life expectancy of 5 days or more
- Agree to participate in the study
You will not qualify if you...
- Known allergy to cephalosporins or history of anaphylaxis to beta-lactam antibiotics
- Clinical signs of hemodynamic instability
- Use of other antibiotics active against Gram-negative bacteria, except prophylactic trimethoprim/sulfamethoxazole
- End-stage chronic kidney failure with creatinine clearance less than 10 ml/min or on dialysis
- Severe (grade IV) mucositis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 5 to 7 days
Participants receive either ceftolozane/tazobactam or piperacillin/tazobactam antibiotics for bacteremia associated with severe neutropenia and fever. Treatment duration depends on clinical and microbiological response, lasting at least 5 to 7 days.
Daily visits for up to 7 days
Follow-up
Duration - Up to 30 days from treatment start
Participants are monitored for clinical status, fever resolution, and adverse events until 30 days after treatment initiation, including a telephone call if discharged before day 30.
Daily visits during hospitalization and 1 telephone call if discharged early
Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cancerologia
Mexico City, Tlalpan, Mexico, 14080
Actively Recruiting
Loading map...
Research Team
D
Diana Vilar Compte, M.D.,M.Sc.
P
Patricia Volkow, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Clinical syndromes and treatment location predict utility of carbapenem sparing therapies in ceftriaxone-non-susceptible Escherichia coli bloodstream infection.
Ouli Xie, Kathryn Cisera, Lucy Taylor...
https://pubmed.ncbi.nlm.nih.gov/33256752Ceftolozane/tazobactam: place in therapy.
Daniele Roberto Giacobbe, Matteo Bassetti, Francesco Giuseppe De Rosa...
https://pubmed.ncbi.nlm.nih.gov/29493397Antimicrobial Activity of Ceftolozane-Tazobactam Tested Against Enterobacteriaceae and Pseudomonas aeruginosa with Various Resistance Patterns Isolated in U.S. Hospitals (2013-2016) as Part of the Surveillance Program: Program to Assess Ceftolozane-Tazobactam Susceptibility.
Dee Shortridge, Michael A Pfaller, Mariana Castanheira...
https://pubmed.ncbi.nlm.nih.gov/29039729Ceftolozane/tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing urinary tract and intraabdominal infections in Europe: report from an antimicrobial surveillance programme (2012-15).
Michael A Pfaller, Matteo Bassetti, Leonard R Duncan...
https://pubmed.ncbi.nlm.nih.gov/28165526Activity of ceftolozane/tazobactam against surveillance and 'problem' Enterobacteriaceae, Pseudomonas aeruginosa and non-fermenters from the British Isles.
David M Livermore, Shazad Mushtaq, Daniele Meunier...
https://pubmed.ncbi.nlm.nih.gov/28520867Ceftolozane-tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing healthcare-associated infections in Australia and New Zealand: Report from an Antimicrobial Surveillance Program (2013-2015).
M A Pfaller, D Shortridge, H S Sader...
https://pubmed.ncbi.nlm.nih.gov/28735046Ceftolozane-tazobactam activity against drug-resistant Enterobacteriaceae and Pseudomonas aeruginosa causing healthcare-associated infections in Latin America: report from an antimicrobial surveillance program (2013-2015).
Michael A Pfaller, Dee Shortridge, Helio S Sader...
https://pubmed.ncbi.nlm.nih.gov/28941394In-vitro activity of ceftolozane/tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae isolates recovered from hospitalized patients in Germany.
Harald Seifert, Barbara Körber-Irrgang, Michael Kresken...
https://pubmed.ncbi.nlm.nih.gov/28705666A Case-Control Study of Real-Life Experience with Ceftolozane-Tazobactam in Patients with Hematologic Malignancy and Pseudomonas aeruginosa Infection.
Ana Fernández-Cruz, Natalia Alba, María Auxiliadora Semiglia-Chong...
https://pubmed.ncbi.nlm.nih.gov/30530598