CompletedNot Applicable

European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems

Albania, Bulgaria, Croatia2,515 participantsStarted 2016-04-27

Plain-language summary

Among antibiotic-resistant organisms, the Gram-negative bacteria are now the most important challenge because of the rapid worldwide spread of mechanisms conferring resistance to multiple drugs. The most recent and worrying problem is the emergence and spread of carbapenemases. Additionally, carbapenem-resistance is known to be very frequent among Acinetobacter baumannii isolates for many years. Overall, the therapeutic options available against carbapenem-resistant Enterobacteriaceae (CRE) and A. baumannii (CRAB) are very limited. The best available treatment (BAT) against CRE is unknown, which is a challenge for therapeutic decisions and also for the design of randomized trials with new drugs. The generic objectives of EURECA are to obtain high-quality observational data to inform the design of randomized controlled trials for complicated intraabdominal infections, pneumonia, complicated urinary tract infections and bloodstream infections due to Carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Acinetobater baumannii, and to provide cohort data that could eventually be used as historical controls for future comparisons with new drugs targeting CRE. This will be achieved by a prospective, multinational cohort study of patients with targeted infections due to CRE and CRAB, and by matched case-control-control studies.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Selection criteria for CRE GROUPS and CRAB GROUP: Inclusion criteria (all must be fulfilled): * Isolation of CRE or CRAB from a clinical sample (e.g., a sample obtained in the work-up of a patient with suspicion of infection; therefore, screening samples are not considered). * The patient meets the criteria for any of the following infections (see definitions below): complicated urinary tract infection, pneumonia, intraabdominal infection or bloodstream infection (if the source of infection is any of the above, the patient will be included in both groups). * Patient or his/her representative sign the inform consent if requested by the local Institutional Review Board (IRB). Patients in these groups will be included until the needed sample sizes are reached. Exclusion Criteria: * The infection is considered to be polymicrobial according to standard microbiological interpretation of culture results (except for cIAI, in which polymicrobial infections are allowed). * The patient was participating in a clinical trial that involved active treatment for the infections. * The patient was previously included in the same cohort of this study for the same organism. A single episode of CRE or CRAB per patient can be included. Patients who suffer a CRE infection could later be included in the CRAB cohort if developing a CRAB infection and vice versa. * Patients with do not resuscitate orders or with a life expectancy of \<30 days. Selection criteria for CSE GROUP Inclusion criteria (…

What they're measuring

Mortality

Timeframe: 30 days

Clinical response (failure vs cure or improvement)

Timeframe: 21 days

Infection due to CRE

Timeframe: 1 year

Length of hospital stay.

Timeframe: 1 year

Trial details

NCT IDNCT02709408

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12-30

View on ClinicalTrials.gov More Carbapenem Resistant Bacteria Infection trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.