Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study. (INCREMENT-SOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02852902
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : March 28, 2019
Sponsor:
Collaborators:
ESCMID Study Group for Bloodstream Infections and Sepsis - ESGBIS
ESCMID Study Group for Antimicrobial Resistance Surveillance - ESGARS
ESCMID Study Group for Infections in Compromised Hosts - ESGICH
Information provided by (Responsible Party):
Spanish Network for Research in Infectious Diseases

Brief Summary:

Main objective: to observationally assess the efficacy and safety of different antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacterales in SOT.

Secondary objectives:

  1. To evaluate the efficacy and safety of different antibiotics used for the treatment of infections caused by ESBL- and carbapenemase-producing Enterobacterales in the SOT population.
  2. To compare the efficacy of different antimicrobials between SOT and non-SOT patients (using matched controls from the "non-transplant" INCREMENT cohort).
  3. To create a microbiological collection of ESBL- and carbapenemase-producing Enterobacterales isolated from the SOT population.
  4. To provide data on specific MICs for each antimicrobial evaluated.
  5. To provide data on the prevalence of specific mechanisms of resistance and their clinical impact in the particular setting of SOT.
  6. To organise an international consortium capable of developing high quality prospective cohort studies and randomised clinical trials in the area of MDR and XDR Enterobacterales in SOT.

Condition or disease
Clinically Significant Bacteremia Organ Transplantation Infection Bacteremia Bacterial Infections Sepsis Systemic Inflammatory Response Syndrome Pathologic Processes Inflammation

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. Cure rate [ Time Frame: 14 days ]
    Cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary


Secondary Outcome Measures :
  1. Mortality at 72 hours [ Time Frame: 72 hours ]
    Dead: death of the patient for whatever the reason.

  2. Mortality at 7 days [ Time Frame: 3 days ]
    Dead: death of the patient for whatever the reason.

  3. Mortality at 14 days [ Time Frame: 14 days ]
    Dead: death of the patient for whatever the reason.

  4. Mortality at 30 days [ Time Frame: 30 days ]
    Dead: death of the patient for whatever the reason.

  5. Clinical Improvement at 72 hours [ Time Frame: 72 hours ]
    mprovement: partial control or resolution of signs and symptoms related to the infection, or resolution but antibiotic therapy is still necessary. Non-improvement or deterioration: clinical situation qualified as similar or worse in comparison to that at the diagnosis of bacteremia.

  6. Clinical cure at 28 days [ Time Frame: 28 days ]
    Clinical Cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Episodes of clinically-significant monomicrobial BSI due to ESBL or carbapenemase-producing Enterobacteriaceae in the solid organ transplant (SOT) population.
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.

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): NCT02852902


Locations
Layout table for location information
Spain
Hospital Universitario Reina Sofía/IMIBIC/Universidad de Córdoba
Córdoba, Spain, 14004
12 de Octubre University Hospital
Madrid, Spain, 28041
Virgen Macarena University Hospital
Seville, Spain, 41009
Sponsors and Collaborators
Spanish Network for Research in Infectious Diseases
ESCMID Study Group for Bloodstream Infections and Sepsis - ESGBIS
ESCMID Study Group for Antimicrobial Resistance Surveillance - ESGARS
ESCMID Study Group for Infections in Compromised Hosts - ESGICH
Investigators
Layout table for investigator information
Principal Investigator: JULIÁN TORRE-CISNEROS, MD, PhD Hospital Universitario Reina Sofía/IMIBIC/UCO, Córdoba, Spain.
Principal Investigator: JESÚS RODRIGUEZ-BAÑO, MD, PhD Hospital Universitario Virgen Macarena, IBIS, Seville, Spain.
Principal Investigator: JOSE MARÍA AGUADO, MD, PhD Hospital Universitario "12 de Octubre", Imas12, Madrid, Spain.
Principal Investigator: ÁLVARO PASCUAL, MD, PhD Hospital Universitario Virgen Macarena, IBIS, Seville, Spain.
Principal Investigator: LUIS MARTÍNEZ-MARTÍNEZ, MD, PHD Hospital Universitario Reina Sofía/IMIBIC/UCO, Córdoba, Spain.
Principal Investigator: BELÉN GUTIÉRREZ-GUTIÉRREZ, MD, PhD Hospital Universitario Virgen Macarena, IBIS, Seville, Spain.
Principal Investigator: ELENA PÉREZ-NADALES, PhD IMIBIC/HURS/UCO, Córdoba, Spain
  Study Documents (Full-Text)

Documents provided by Spanish Network for Research in Infectious Diseases:

Layout table for additonal information
Responsible Party: Spanish Network for Research in Infectious Diseases
ClinicalTrials.gov Identifier: NCT02852902     History of Changes
Other Study ID Numbers: REIPI-3.50
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There will be a single registry of clinical data for this project. Data will be submitted by all centers to an electronic Clinical Research File (CRF). Once the deadline for data collection is close, data will be exported to a file which will be treated as confidential, complying with all guarantees for data protection according to Spanish legislation. Investigators from the consortium will have access to all data from their own institution at all times. Access to the whole database will be provided after specific requests for defined analysis and publications, always after approval by the Scientific Committee. This clinical file will be saved for an estimated period of three years in order to allow the necessary time for publication of results.

Keywords provided by Spanish Network for Research in Infectious Diseases:
Bloodstream infections caused by MDR Enterobacteriaceae
Extended-spectrum β-lactamase-producers
Carbapenemase-producing organisms
Solid Organ Transplantation
Multidrug-resistant Enterobacteriaceae
Anti-Infective Agents

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents
Infection
Communicable Diseases
Bacterial Infections
Bacteremia
Inflammation
Systemic Inflammatory Response Syndrome
Pathologic Processes
Sepsis
Shock