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Gram-negative Bacteremia in HSCT Recipients (GNB)

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ClinicalTrials.gov Identifier: NCT02257931
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
European Group for Blood and Marrow Transplantation

Brief Summary:
A significant increase in resistant bacteria emerging in HSCT recipients. For example, 25% - 42% of all enterobacteriaceae produce extended spectrum beta-lactamases; 8 - 72% of Pseudomonas aeruginosa are resistant to at least one and 25 - 62% to three or more antibiotic classes, 13% of Gram-negative bacteria are caused by a multidrug-resistant (MDR) strain (Trecarichi JI 09, Mikulska BBMT 09, Oliveira BMT 07, Caselli Haemat 10, Gudiol, JAC 11). These resistant bacteria may be associated with increased mortality and have limited treatment options (Caselli Haemat 10, Poutsiaka BMT 07, DiazGranadoz JID 05). To provide the currently best empirical coverage and to control the growing resistance, knowledge of trends in antibiotic susceptibility, as well as risk factors is essential. For this reason we propose to perform non-interventional prospective multicentre study in EBMT centres.

Condition or disease
Allogeneic or Autologous HSCT

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 591 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Resistance Pattern of Gram-negative Bacteria Isolated From Blood From HSCT Recipients.
Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2017

Group/Cohort
HSCT recipient
Allogeneic or autologous HSCT recipients, of all ages, for any indications. From this group we take those with a gram-negative bacteremia within 6 months after HSCT.



Primary Outcome Measures :
  1. The proportion of resistant pathogens among gram-negative bacterial pathogens isolated from blood of HSCT recipients during the first 6 months post HSCT. [ Time Frame: 6 months after HSCT ]
    1. Pathogens resistant to either one of the following: ceftazidime or cefepime or piperacillin-tazobactam
    2. Pathogens with carbapenem resistance (not including ertapenem)
    3. MDR pathogens


Secondary Outcome Measures :
  1. The proportion of resistant Gram-negative pathogens not listed in the primary end-point among Gram-negative bacterial pathogens isolated from blood of HSCT recipients during the first 6 months post HSCT: [ Time Frame: 6 months after HSCT ]

    Gram-negative pathogens resistant to fluoroquinolones

    • Gram-negative pathogens resistant to at least one of aminoglycosides
    • Gram-negative pathogens resistant to colistin
    • Gram-negative pathogens (other than Pseudomonas) resistant to tigecyclin
    • Acinetobacter spp. resistant to ampicillin-sulbactam
    • Acinetobacter spp. resistant to tetracyclin or minocycline
    • Stenotrophomonas maltophilia resistant to trimethoprim-sulfamethoxazole
    • Stenotrophomonas maltophilia resistant to minocycline


Other Outcome Measures:
  1. The outcome of the infections caused by resistant pathogens vs. sensitive, including mortality of any cause within 7 days and within 30 days; [ Time Frame: 30 days after HSCT ]
  2. The appropriateness of the currently administered empirical antimicrobial therapy [ Time Frame: 6 months after HSCT ]
    The appropriateness of the currently administered empirical antimicrobial therapy; Inappropriate initial antimicrobial therapy will be defined as empirical antibiotic regimen, given in the first 48 hours following obtaining the blood cultures, that does not include at least one antibiotic that is active in vitro against the infecting microorganism.



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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
eligible patients from EBMT centres
Criteria

Inclusion Criteria:

  • Allogeneic or autologous HSCT recipients, of all ages, for any indications.

Exclusion Criteria:

  • Patients who are not willing to participate.

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): NCT02257931


Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium
China
First Affiliated Hospital of Soochow University
Suzhou, China
Croatia
University Hospital Center Rebro
Zagreb, Croatia
Germany
University of Muenster
Muenster, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg, Germany
Israel
Rambam Medical Center
Haifa, Israel
Portugal
Inst. Portugues de Oncologia do Porto
Porto, Portugal
Russian Federation
Federal Research Centre for Pediatric Hematology
Moscow, Russian Federation
Sweden
Karolinska University Hospital
Stockholm, Sweden
Turkey
Anadolu Medical Center
Kocaeli, Turkey
Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
Investigators
Principal Investigator: Dina Averbuch, MD Hadassah University Hospital, Pediatric Infectious Diseases Unit, Jerusalem, Israel
Principal Investigator: Dan Engelhard, MD Hadassah University Hospital, Pediatric Infectious Diseases Unit, Jerusalem, Israel
Study Chair: Simone Cesaro, MD Policlinico G.B. Rossi, paediatric haematology oncology, Verona, Italy