Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT02852902
Eligibility Criteria:
Inclusion Criteria:
* Solid Organ Transplant patients, including multivisceral transplantation and transplant in HIV-infected recipients.
* Episodes of clinically significant monomicrobial BSI due to cephalosporin-resistant Enterobacterales (CRE), specifically ESBL or carbapenemase-producing Enterobacterales, including community and nosocomial ones. Characterization of the resistance mechanisms should be based on the following criteria:
* For cephalosporin resistance: a susceptibility phenotype based on a microdilution antibiogram.
* For ESBL-producers: one phenotypic confirmation test according to current endpoints (i.e. CLSI, EUCAST) or PCR-based characterization.
* For carbapenemase-producers: molecular detection of the carbapenemase gene or if the isolate showed an identical phenotype to previously characterized carbapenemase-producers detected at the same site.
* Subsequent episodes in a patient caused by the same microorganism may be included if the interval between them is \>3 months.
Exclusion Criteria:
* Polymicrobial or non-clinically significant episodes. Episodes in which a potential contaminant (e.g., coagulase-negative staphylococci) is isolated only in one set of blood cultures and there is not a typical source of infection for that kind of organism (e.g. catheter-related) that can be included.
* Unavailability of key data (such cases should be counted to analyse a potential selection bias).
* Episodes occurring before January 2004.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02852902
Study Brief:
Protocol Section:
NCT02852902