CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 265 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06419296
NCT06419296N/ACompleted

Mortality of MBL-producing Enterobacteriaceae Bacteremias with the Combined Use of Ceftazidime-avibactam and Aztreonam Vs. Other Active Antibiotics. a Multicenter Target Trial Emulation.

Hospital Italiano de Buenos Aires·observational·Posted May 17, 2024·Updated Nov 21, 2024

In Brief

An observational study for Bacteremia. Completed, enrolled 265 participants across 16 sites.

Detailed Summary

Ceftazidime-avibactam and aztreonam combination (CAZAVI + ATM) presents a potential alternative for the treatment of metallo-beta-lactamase (MBL)-type carbapenemase-producing Enterobacteriaceae (CPE) bacteremia, particularly where Cefiderocol is not readily available. This study proposes a Target Trial Emulation (TTE) to assess the efficacy and safety of CAZAVI + ATM compared to other active antibiotics (OAAs) in patients with MBL-type CPE bacteremia, and also to evaluate all-cause 30-day mortality, resistance profiles of isolated microorganisms, clinical failure rates, leukocyte count normalization, adverse events, occurrence of Clostridium difficile infection, and emergence of new multidrug-resistant microorganisms. Data will be collected through the REDCap database, with rigorous verification for completeness and accuracy. The outcomes of this project will contribute vital insights into the efficacy and safety of CAZAVI + ATM, informing clinical practice guidelines for the management of MBL-type bacteremia across diverse settings.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBacteremia
CountriesArgentina
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedMay 17, 2024
Enrollment StartJun 1, 2024
Primary CompletionNov 19, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.1 years ago