Actively Recruiting
Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2024-06-04
226
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with hematological malignancies receive highly myelotoxic chemotherapy regimens that cause periods of severe myelosuppression, which places them at high risk of developing bacteremia. At a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR P.aeruginosa, have been described during the last decade. Among the strategies to reduce bacterial resistance, ceftolozane/tazobactam (C/T) as a "carbapenem-sparing" antibiotic has been proposed. C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteriaceae 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. At the National Cancer Institute (in Spanish, Instituto Nacional de Cancerologia), Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia. Escherichia coli occupies the first place in 25% (41% ESBL), followed by Klebsiella spp. in 5.6% (11.2% ESBL) and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hematological malignancy patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin/tazobactam (P/T). In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P/T-resistant bacteria are identified, this is escalated to carbapenem. Therefore, it is proposed to compare the clinical and microbiological response in patients with hematological malignancies who present with severe neutropenia and fever and who present clinical data of bacteremia, with empirical treatment with C/T vs. P/T, trying to reduce the use of carbapenems in this group of patients.
CONDITIONS
Official Title
Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Diagnosis of any hematological malignancy
- Severe neutropenia with polymorphonuclear cells less than 500/mm3
- Fever of 38.3°C or higher in one measurement or 38°C or higher in at least two measurements
- Median arterial pressure of at least 65 mmHg 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 severe allergic reaction to beta-lactams
- Signs of hemodynamic instability
- Using other antibiotics active against Gram-negative bacteria (except TMP/SMX prophylaxis)
- End-stage chronic kidney failure (creatinine clearance below 10 ml/min) or on dialysis
- Severe mucositis grade IV
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cancerologia
Mexico City, Tlalpan, Mexico, 14080
Actively Recruiting
Research Team
D
Diana Vilar Compte, M.D.,M.Sc.
CONTACT
P
Patricia Volkow, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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