NCT02852902

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. 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. 2.To compare the efficacy of different antimicrobials between SOT and non-SOT patients (using matched controls from the "non-transplant" INCREMENT cohort).
  3. 3.To create a microbiological collection of ESBL- and carbapenemase-producing Enterobacterales isolated from the SOT population.
  4. 4.To provide data on specific MICs for each antimicrobial evaluated.
  5. 5.To provide data on the prevalence of specific mechanisms of resistance and their clinical impact in the particular setting of SOT.
  6. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
820

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

July 28, 2016

Last Update Submit

March 26, 2019

Conditions

Clinically Significant BacteremiaOrgan TransplantationInfectionBacteremiaBacterial InfectionsSepsisSystemic Inflammatory Response SyndromePathologic ProcessesInflammation

Keywords

Bloodstream infections caused by MDR EnterobacteriaceaeExtended-spectrum β-lactamase-producersCarbapenemase-producing organismsSolid Organ TransplantationMultidrug-resistant EnterobacteriaceaeAnti-Infective Agents

Outcome Measures

Primary Outcomes (1)

  • Cure rate

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

    14 days

Secondary Outcomes (6)

  • Mortality at 72 hours

    72 hours

  • Mortality at 7 days

    3 days

  • Mortality at 14 days

    14 days

  • Mortality at 30 days

    30 days

  • Clinical Improvement at 72 hours

    72 hours

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Episodes of clinically-significant monomicrobial BSI due to ESBL or carbapenemase-producing Enterobacteriaceae in the solid organ transplant (SOT) population.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario Reina Sofía/IMIBIC/Universidad de Córdoba

Córdoba, 14004, Spain

Location

12 de Octubre University Hospital

Madrid, 28041, Spain

Location

Virgen Macarena University Hospital

Seville, 41009, Spain

Location

Related Publications (3)

  • Perez-Nadales E, Fernandez-Ruiz M, Natera AM, Gutierrez-Gutierrez B, Mularoni A, Russelli G, Pierrotti LC, Pinheiro Freire M, Falcone M, Tiseo G, Tumbarello M, Raffaelli F, Abdala E, Bodro M, Gervasi E, Farinas MC, Seminari EM, Caston JJ, Marin-Sanz JA, Galvez-Soto V, Rana MM, Loeches B, Martin-Davila P, Pascual A, Rodriguez-Bano J, Aguado JM, Martinez-Martinez L, Torre-Cisneros J; REIPI/INCREMENT-SOT Study Group. Efficacy of ceftazidime-avibactam in solid organ transplant recipients with bloodstream infections caused by carbapenemase-producing Klebsiella pneumoniae. Am J Transplant. 2023 Jul;23(7):1022-1034. doi: 10.1016/j.ajt.2023.03.011. Epub 2023 Apr 5.

    PMID: 37028515DERIVED

  • Pierrotti LC, Perez-Nadales E, Fernandez-Ruiz M, Gutierrez-Gutierrez B, Tan BH, Carratala J, Oriol I, Paul M, Cohen-Sinai N, Lopez-Medrano F, San-Juan R, Montejo M, Freire MP, Cordero E, David MD, Merino E, Mehta Steinke S, Grossi PA, Cano A, Seminari EM, Valerio M, Gunseren F, Rana M, Mularoni A, Martin-Davila P, van Delden C, Hamiyet Demirkaya M, Kocak Tufan Z, Loeches B, Iyer RN, Soldani F, Eriksson BM, Pilmis B, Rizzi M, Coussement J, Clemente WT, Roilides E, Pascual A, Martinez-Martinez L, Rodriguez-Bano J, Torre-Cisneros J, Aguado JM; Investigators from the REIPI/INCREMENT-SOT Group. Efficacy of beta-lactam/beta-lactamase inhibitors to treat extended-spectrum beta-lactamase-producing Enterobacterales bacteremia secondary to urinary tract infection in kidney transplant recipients (INCREMENT-SOT Project). Transpl Infect Dis. 2021 Jun;23(3):e13520. doi: 10.1111/tid.13520. Epub 2021 Jan 4.

    PMID: 33222379DERIVED

  • Perez-Nadales E, Gutierrez-Gutierrez B, Natera AM, Abdala E, Reina Magalhaes M, Mularoni A, Monaco F, Camera Pierrotti L, Pinheiro Freire M, Iyer RN, Mehta Steinke S, Grazia Calvi E, Tumbarello M, Falcone M, Fernandez-Ruiz M, Maria Costa-Mateo J, Rana MM, Mara Varejao Strabelli T, Paul M, Carmen Farinas M, Clemente WT, Roilides E, Munoz P, Dewispelaere L, Loeches B, Lowman W, Tan BH, Escudero-Sanchez R, Bodro M, Antonio Grossi P, Soldani F, Gunseren F, Nestorova N, Pascual A, Martinez-Martinez L, Aguado JM, Rodriguez-Bano J, Torre-Cisneros J; REIPI/INCREMENT-SOT Investigators. Predictors of mortality in solid organ transplant recipients with bloodstream infections due to carbapenemase-producing Enterobacterales: The impact of cytomegalovirus disease and lymphopenia. Am J Transplant. 2019 Dec 31. doi: 10.1111/ajt.15769. Online ahead of print.

    PMID: 31891235DERIVED

MeSH Terms

Conditions

InfectionsBacteremiaBacterial InfectionsSepsisSystemic Inflammatory Response SyndromePathologic ProcessesInflammation

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesPathological Conditions, Signs and SymptomsShock

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

January 1, 2016

Primary Completion

October 31, 2016

Study Completion

January 1, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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.

Locations

ES(3)