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Survey of Severe Infections by Gram Negative Bacteria in Patients Submitted to Stem Cell Transplant (GITMO-SIGNB)

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ClinicalTrials.gov Identifier: NCT02088840
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Trapianto di Midollo Osseo

Study Description
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Brief Summary:
All patients undergoing autologous or allogeneic stem cell transplant (SCT) for any underlying disease will be monitored for severe infections by gram negative bacteria (SIGNB) during the engraftment period. The follow up will be stopped at 4 months from the day of transplant. About 50 transplant centers will be involved in the study.

Condition or disease
Complications of Organ Transplant Stem Cells Gram-Negative Bacterial Infections

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Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 2769 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: A Prospective, Multicenter Survey of Severe Infections by Gram Negative Bacteria in Patients Submitted to Autologous and Allogeneic Stem Cell Transplant.
Study Start Date : January 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016
Groups and Cohorts
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Group/Cohort
stem cell tranplant
All patients undergoing autologous or allogeneic stem cell tranplant for any underlying disease


Outcome Measures
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Primary Outcome Measures :
  1. incidence of each type of Severe Infections by Gram Negative Bacteria [ Time Frame: 4 months by stem cell transplant ]
    To estimate the incidence of each type of Severe Infections by Gram Negative Bacteria , in particular by antibiotic resistant isolates, documented during the engraftment period in patients submitted to autologous and allogeneic stem cell transplant.


Secondary Outcome Measures :
  1. incidence particularly of Severe Infections by Gram Negative Bacteria [ Time Frame: 4 months by stem cell transplant ]
    To assess the incidence of Severe Infections by Gram Negative Bacteria particularly those caused by antibiotic resistant enterobacteria in subgroups of patients undergoing autologous or allogeneic stem cell transplant.

  2. risk factors [ Time Frame: 4 month by stem cell transplant ]
    To assess the risk factors of Severe Infections by Gram Negative Bacteria particularly those caused by antibiotic resistant enterobacteria in autologous and allogeneic Stem cell CT transplant

  3. prognostic factors [ Time Frame: 4 month by stem cell transplant ]
    To assess the prognostic factors of Severe Infections by Gram Negative Bacteria particularly those caused by antibiotic resistant enterobacteria in autologous and allogeneic Stem cell CT transplant

  4. overall mortality for SIGNB [ Time Frame: 3 months from the Severe Infections by Gram Negative Bacteria ]
    To assess the overall Severe Infections by Gram Negative Bacteria and attributable mortality at 3 months from the SIGNB

  5. overall survival for SIGNB from transplant [ Time Frame: 4 months from transplant ]
    To assess the impact of SIGNB on the overall survival at 4 months from transplant in autologous and allogeneic Stem Cell Transplantation

  6. susceptibility pattern to antimicrobials of microorganisms [ Time Frame: 4 month by stem cell transplant ]
    To evaluate the susceptibility pattern to antimicrobials of microorganisms causing Severe Infections by Gram Negative Bacteria with particular attention to enterobacteria with particular attention to the resistance phenotypes

  7. antibacterial strategies [ Time Frame: 4 month by stem cell transplant ]
    To describe the antibacterial strategies (in prophylaxis and therapy) employed in the various centers and in the various categories of patients particularly for the management of antibiotic resistant enterobacteria

  8. local strategy [ Time Frame: 4 month by stem cell transplant ]
    To evaluate the impact of a local strategy in the use of antibiotics on the epidemiology of Severe Infections by Gram Negative Bacteria


Eligibility Criteria
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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
All patients undergoing autologous or allogeneic Stem Cell Transplant for any underlying disease will be monitored for SIGNB during the engraftment period.
Criteria

Inclusion Criteria:

All consecutive patients submitted to autologous or allogeneic SCT at the Centers participating to the survey Signed written informed consent according to IGH/EU/GCP and national local laws.

Without age limit

Exclusion Criteria:

Patients who did not sign written informed consent

Contacts and Locations
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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): NCT02088840


Locations
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Sponsors and Collaborators
Gruppo Italiano Trapianto di Midollo Osseo
Investigators
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Principal Investigator: Corrado Girmenia, MD Policlinico Umberto I - Rome
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier: NCT02088840    
Other Study ID Numbers: SIGNB-GITMO-AMCLI-Survey
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by Gruppo Italiano Trapianto di Midollo Osseo:
SIGNB
severe infections gram negative bacteria
stem cell transplant
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Gram-Negative Bacterial Infections