Status:
TERMINATED
Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Carbapenem-Resistant Enterobacteriaceae Infection
Bloodstream Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited. Recently approved drugs, such as bela-lactam/beta-lactamase ...
Eligibility Criteria
Inclusion
- Primary or secondary bloodstream infections by any specie of the Enterobacterales family with minimum inhibitory concentration (MIC) for meropenem \>32mg/L;
- Agreement of the assistant team with the inclusion of the patient in the study;
- Agreement by the patient or legal guardian to sign the informed consent form.
Exclusion
- Known pregnancy;
- Patients belonging to the population deprived of their liberty;
- Known allergy to meropenem;
- Use of ceftazidime-avibactam (or any other new antimicrobial agent that become available in Brazil during the study period) for the treatment of the current infection;
- Infection by an Enterobacterales isolates without in vitro susceptibility to at least one antimicrobial drug;
- Bloodstream co-infection by another gram negative bacilli;
- Concomitant infection at any site by a pathogen which meropenem is indicated;
- Neutropenia (\<1000 neutrophils cells/mm3)
- Death expected within 48 hours of eligibility assessment.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04876430
Start Date
May 4 2021
End Date
March 7 2022
Last Update
August 3 2022
Active Locations (2)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
2
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90619-900