Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342115
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-29
Brief Title:
CeftolozaneTazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
Sponsor:
Beneficência Portuguesa de São Paulo
Organization:
Beneficência Portuguesa de São Paulo
Study Overview
Official Title:
CeftolozaneTazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase ESBL-Producing Pathogens a Randomized Double-blind Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEMENT
Brief Summary:
The study proposes a planned double-blind non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase ESBL infection The goal is
- Analyze the efficacy and tolerability of Ceftolozanetazobactam CEFTAZ compared to the current standard of care meropenem in patients with febrile neutropenia and risk of ESBL infection
Patients will be randomly assigned to receive CEFTAZ or meropenem with assessment of clinical response toxicity and microbiological evolution Stool samples will be collected before during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD Analysis of the results will include the taxonomic classification of the organisms present Data will be analyzed to assess non-inferiority in clinical response incidence of GVHD antimicrobial resistance and other outcomes
- Analyze the efficacy and tolerability of Ceftolozanetazobactam CEFTAZ compared to the current standard of care meropenem in patients with febrile neutropenia and risk of ESBL infection
Patients will be randomly assigned to receive CEFTAZ or meropenem with assessment of clinical response toxicity and microbiological evolution Stool samples will be collected before during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD Analysis of the results will include the taxonomic classification of the organisms present Data will be analyzed to assess non-inferiority in clinical response incidence of GVHD antimicrobial resistance and other outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None