CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,515 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02709408
NCT02709408N/ACompleted

Prospective Observational Study to Assess the Risk Factors, Clinical Management and Outcomes of Hospitalized Patients With Serious Infections Caused by Carbapenem-resistant Enterobacteriaceae and Acinetobacter Baumannii

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla·observational·Posted Mar 16, 2016·Updated Feb 21, 2021

In Brief

An observational study for Carbapenem Resistant Bacteria Infection. Completed, enrolled 2,515 participants across 50 sites in 11 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAlbania, Bulgaria, Croatia, Greece, Italy, Kosovo, Montenegro, Romania, Serbia, Spain, Turkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartApr 27, 2016
Primary CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.3 years ago