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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.

NCT02852902 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 820

Last updated 2019-03-28

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • European Society of Clinical Microbiology and Infectious Diseases

    collaborator OTHER

  • Spanish Network for Research in Infectious Diseases

    lead OTHER

Principal Investigators

  • JULIÁN TORRE-CISNEROS, MD, PhD · Hospital Universitario Reina Sofía/IMIBIC/UCO, Córdoba, Spain.

  • JESÚS RODRIGUEZ-BAÑO, MD, PhD · Hospital Universitario Virgen Macarena, IBIS, Seville, Spain.

  • JOSE MARÍA AGUADO, MD, PhD · Hospital Universitario "12 de Octubre", Imas12, Madrid, Spain.

  • ÁLVARO PASCUAL, MD, PhD · Hospital Universitario Virgen Macarena, IBIS, Seville, Spain.

  • LUIS MARTÍNEZ-MARTÍNEZ, MD, PHD · Hospital Universitario Reina Sofía/IMIBIC/UCO, Córdoba, Spain.

  • BELÉN GUTIÉRREZ-GUTIÉRREZ, MD, PhD · Hospital Universitario Virgen Macarena, IBIS, Seville, Spain.

  • ELENA PÉREZ-NADALES, PhD · IMIBIC/HURS/UCO, Córdoba, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-10-31
Completion
2018-01-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02852902 on ClinicalTrials.gov