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

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 |
Group/Cohort |
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stem cell tranplant
All patients undergoing autologous or allogeneic stem cell tranplant for any underlying disease
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- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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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 |
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

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

Principal Investigator: | Corrado Girmenia, MD | Policlinico Umberto I - Rome |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
SIGNB severe infections gram negative bacteria stem cell transplant |
Infection Communicable Diseases Bacterial Infections Gram-Negative Bacterial Infections |