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European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems (EURECA)

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ClinicalTrials.gov Identifier: NCT02709408
Recruitment Status : Unknown
Verified August 2017 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Recruitment status was:  Recruiting
First Posted : March 16, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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.

Condition or disease
Carbapenem Resistant Bacteria Infection

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1025 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Group/Cohort
Carbapenem-resistant Enterobacteriaceae
Patients with complicated intrabdominal infections, pneumonia, complicated urinary tract infection and bloodstream infection due to carbapenem-resistant Enterobacteriaceae
Carbapenem-resistant A. baumannii
Patients with bloodstream infections due to carbapenem-resistant Acinetobacter baumannii
Susceptible Enterobacteriaceae
Patients with complicated intrabdominal infections, pneumonia, complicated urinary tract infection and bloodstream infection due to carbapenem-susceptible Enterobacteriaceae matched to carbapenem-resistant ones by centre, type of ward, infection type, acquisition and previous duration of hospitalisation.
Admitted control patients
Patients without infection due to Enterobacteriaceae matched to carbapenem-resistant Enterobacteriaceae cases according to centre, ward and previous length of hospitalisation.



Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Death by any caused

  2. Clinical response (failure vs cure or improvement) [ Time Frame: 21 days ]

    Clinical failure: non-improvement or deterioration (clinical situation qualified as similar or worse in comparison to that at the diagnosis of bacteremia), death (death of the patient for whatever the reason) or relapse (reappearance of signs and symptoms related to the infection, after the end of treatment).

    Clinical cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary.

    Clinical improvement: resolution or partial improvement of signs or symptoms of the infection at the time of assessment but antibiotic therapy is still needed.

    TOC was decided at day 21 because it is usually 7 days after the expected average duration of therapy, which is around 10-14 days for the infections included.


  3. Infection due to CRE [ Time Frame: 1 year ]
    Infection due to CRE (study 2)

  4. Length of hospital stay. [ Time Frame: 1 year ]
    Duration of hospitalisation (study 3)


Secondary Outcome Measures :
  1. Microbiological response (microbiological eradication, failure or uncertain). [ Time Frame: 21 days ]

    Microbiological eradication: follow-up cultures from the infection site are negative for the causative pathogen; if follow-up cultures were not performed for clinical reasons but there is clinical cure, the case is classified as "microbiological eradiation, presumptive".

    Microbiological failure: follow-up cultures from the infection site are still positive for the causative pathogen.

    Uncertain: follow-up cultures were not performed but there is no clinical cure.


  2. Mortality during hospitalisation. [ Time Frame: 1 year ]
    Death from any cause only during the hospitalisation of the patient.

  3. Infection-related mortality [ Time Frame: 30 days ]
    Death occurring in direct relation to the infection or its complications, and without any other alternative reasonable explanation, in opinion of the local investigator.

  4. Length of hospital stay after the infection (and ICU stay, mechanical ventilation if appropriate). [ Time Frame: After end of hospitalisation ]
    Duration of hospitalisation (and in ICU or of mechanical ventilation if appropriate).

  5. Duration of antibiotic treatment for the episode. [ Time Frame: 30 days ]
    Days of antibiotic therapy for the infection

  6. Recurrence [ Time Frame: 30 days ]
    Reappearance of infection by the same organism.

  7. Superinfection [ Time Frame: 30 days ]
    Occurrence of any infection by a different organism.

  8. Therapy-related adverse events. [ Time Frame: 30 days ]
    Moderate to severe adverse events related to treatment of the infection.


Biospecimen Retention:   Samples With DNA
Bacteria (carbapenem-resistant and susceptible Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The base-population for the studies are:

  • Study 1: all patients with the targeted infections due to CRE or CRAB.
  • Study 2 and study 3: all admitted patients with the targeted infections due to CRE or CSE, and all admitted patients.
Criteria

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 (all must be fulfilled)
  • Isolation of CSE 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).
  • The infection is the same as that of the index case; in case of BSI, the source of bacteraemia must be the same as the index case classified as follows: UTI, pneumonia, intraabdominal infection or any other.
  • The type of acquisition is the same as for the index CRE case (nosocomial or community).
  • The previous length of hospitalization before the infection onset is minus 1 up to minus 3 days the previous length of hospitalization before the CRE infection date in the CRE correspondent (up to minus 7 days if the CRE case occurred after 14 days of previous stay).
  • The patient was admitted to the same type of service as the index case (medical, surgical, ICU, neonatal Unit, paediatric ICU, general paediatric wards).
  • Patient or his/her representative sign the inform consent (if requested by local IRB).

Patients in this group will be included until the needed sample size is 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).
  • Patient is participating in a clinical trial that involved active treatment for the infections at assessment.
  • Patients with do not resuscitate orders or with a life expectancy of <30 days. The first patient found with all inclusion criteria and no exclusion criteria will be included.

Selection criteria for ADMITTED CONTROL GROUP Inclusion criteria (all must be fulfilled)

  • Patient is admitted in the same hospital ward where was admitted the index CRE.
  • The previous length of hospitalization is at least one day less than the previous duration of hospitalisation of the correspondent CRE case when the CRE infection occurred.
  • Patient or his/her representative sign the inform consent (if requested by local IRB).

Patients in this group will be included until the needed sample size is reached.

Exclusion criteria

  • Patient was participating in a clinical trial that involved active treatment for the infections at assessment.
  • Patients with do not resuscitate orders or with a life expectancy of <30 days.

Because the search for CSE controls is more difficult, the search for admitted control patients can be started once a CSE control has been included; the first 3 patients with the above inclusion criteria and no exclusion criteria will be included.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709408


Contacts
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Contact: Belén Gutiérrez, MD, PhD belengutiguti@hotmail.com
Contact: Jesús Sojo, MD jesodo@hotmail.com

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Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Study Chair: Jesús Rodríguez Baño, MD, PhD FISEVI (Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT02709408     History of Changes
Other Study ID Numbers: COMBACTE-CARE WP1A
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Within COMBACTE consortium
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Carbapenem resistance
Enterobacteriaceae
Acinetobacter baumannii
Bloodstream infections
Intrabdominal infections
Urinary tract infections
Pneumonia
Risk factors
Outcome
Hospitalised patients
Mortality
Clinical response
Length of hospital stay
Additional relevant MeSH terms:
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Infection
Communicable Diseases