Trials
Search / Trial NCT06419296

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

Launched by HOSPITAL ITALIANO DE BUENOS AIRES · May 14, 2024

Trial Information

Current as of February 12, 2025

Completed

Keywords

Multicenter Target Trial Emulation Bacteremia Metallo Beta Lactamase Carbapenemase Producing Enterobacteriaceae Ceftazidime Avibactam Aztreonam

ClinConnect Summary

Patients will be categorized into two treatment groups for analysis:

CAZAVI + ATM treatment group and Other Active Antibiotics treatment group. As this study is retrospective, treatment group assignment will not be a randomized procedure. Allocation data will be collected from medical records as a dichotomous variable.

In the present study, allocation to CAZAVI + ATM or OAAs will depend on various factors such as drug availability, hospital costs, and medical criteria. Therefore, to ensure comparability among participant characteristics, baseline factors will be adjusted to mitigate indic...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients aged 18 years or older
  • Confirmed bacteremia by MBL-type Carbapenemase-Producing Enterobacteriaceae (CPE)
  • Initiation of effective antibiotic therapy within 24 hours of identification of MBL-type CPE and within 96 hours of blood sample.
  • Exclusion Criteria:
  • * Bacteremia due to the following complicated infections:
  • Endocarditis or other endovascular infection without extractable focus.
  • Necrotizing fasciitis
  • Osteomyelitis or septic arthritis
  • Confirmed prostatitis
  • Non-drainable abscess or other unresolved infection requiring surgical intervention (e.g., cholecystitis)
  • Central nervous system infections
  • Empyema
  • Successive episodes of bacteremia by the same pathogen (with the same resistance profile) within the previous 60 days.
  • Polymicrobial bacteremias, not classified as contaminants.
  • Patients with documented allergy to beta-lactams.

Trial Officials

Ivan Huespe, MD, MPh

Study Director

Hospital Italiano de Buenos Aires

About Hospital Italiano De Buenos Aires

Hospital Italiano de Buenos Aires is a leading healthcare institution dedicated to advancing medical research and patient care. Renowned for its commitment to clinical excellence and innovation, the hospital actively participates in a range of clinical trials aimed at developing new treatment modalities and improving healthcare outcomes. With a multidisciplinary team of experienced healthcare professionals, Hospital Italiano combines cutting-edge technology with a patient-centered approach, ensuring the highest standards of safety and efficacy in all research endeavors. As a trusted sponsor, the hospital is committed to contributing to the global medical community through rigorous scientific investigations and collaboration with various stakeholders.

Locations

Pilar, Buenos Aires, Argentina

Bahía Blanca, Buenos Aires, Argentina

Haedo, Buenos Aires, Argentina

Monte Grande, Buenos Aires, Argentina

San Isidro, Buenos Aires, Argentina

Sarandí, Buenos Aires, Argentina

Rosario, Santa Fe, Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Cordoba, , Argentina

Formosa, , Argentina

Santa Fe, , Argentina

Santa Fe, , Argentina

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0