Survey of Severe Infections by Gram Negative Bacteria in Patients Submitted to Stem Cell Transplant
GITMO-SIGNB
A Prospective, Multicenter Survey of Severe Infections by Gram Negative Bacteria in Patients Submitted to Autologous and Allogeneic Stem Cell Transplant.
1 other identifier
observational
2,769
1 country
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Typical duration for all trials
54 active sites
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, 2014
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedAugust 20, 2021
August 1, 2021
2.2 years
March 13, 2014
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of each type of Severe Infections by Gram Negative Bacteria
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.
4 months by stem cell transplant
Secondary Outcomes (8)
incidence particularly of Severe Infections by Gram Negative Bacteria
4 months by stem cell transplant
risk factors
4 month by stem cell transplant
prognostic factors
4 month by stem cell transplant
overall mortality for SIGNB
3 months from the Severe Infections by Gram Negative Bacteria
overall survival for SIGNB from transplant
4 months from transplant
- +3 more secondary outcomes
Study Arms (1)
stem cell tranplant
All patients undergoing autologous or allogeneic stem cell tranplant for any underlying disease
Eligibility Criteria
All patients undergoing autologous or allogeneic Stem Cell Transplant for any underlying disease will be monitored for SIGNB during the engraftment period.
You may qualify if:
- 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
You may not qualify if:
- Patients who did not sign written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
FPO Irccs
Candiolo, Torino, Italy
Azienda Ospedaliera SS Antonio e Biagio
Alessandria, Italy
Clinica di Ematologia - Università Politecnica delle Marche
Ancona, Italy
Ospedale Mazzoni
Ascoli Piceno, Italy
Policlinico di Bari-Ematologia con trapianti
Bari, Italy
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, Italy
Ospedale San Orsola
Bologna, Italy
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia, Italy
Spedali Civili
Brescia, Italy
Ospedale Binaghi
Cagliari, Italy
Ospedale Ferrarotto - Ematologia
Catania, Italy
Ospedale Civile USL 8
Civitanova Marche, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Cattedra di Ematologia - Azienda Ospedaliera di Careggi
Florence, Italy
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
Foggia, Italy
AOU IRCCS San Martino - IST
Genova, Italy
Ospedale Gaslini
Genova, Italy
Divisione di Ematologia - Istituto Nazionale dei Tumori
Milan, Italy
IEO
Milan, Italy
Ospedale Maggiore Policlinico
Milan, Italy
Ospedale San Raffaele
Milan, Italy
A.O.U. Policlinico Federico II
Napoli, Italy
INT IRCCS Fondazione Pascale
Napoli, Italy
Ospedale Maggiore della Carità
Novara, Italy
AO Ospedali Riuniti Villa Sofia - Cervello
Palermo, Italy
Dipartimento Oncologico La Maddalena
Palermo, Italy
CTMO Università
Parma, Italy
Fondazione IRCCS San Matteo
Pavia, 27100, Italy
Dipartimento di Ematologia - IRCCS Policlinico S. Matteo - Università di Pavia
Pavia, Italy
Dip. Medicina Clinica e Sperimentale
Perugia, Italy
Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
Pescara, Italy
Ospedale G. Da Saliceto di Piacenza
Piacenza, Italy
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
Reggio Calabria, Italy
Ospedale Infermi
Rimini, Italy
Irccs Crob
Rionero in Vulture, Italy
A.O. San Camillo
Roma, Italy
Campus biomedico
Roma, Italy
Cattedra di Ematologia - Policlinico
Roma, Italy
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
Roma, Italy
Istituto Regina Elena IFO
Roma, Italy
Ospedale Bambin Gesù
Roma, Italy
Ospedale San Giovanni
Roma, Italy
Ospedale Sant'Andrea
Roma, Italy
Ospedale Santo Eugenio
Roma, Italy
Policlinico Universitario Tor Vergata
Roma, Italy
Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
Rozzano (MI), Italy
Ospedale Moscati
Taranto, Italy
Azienda ospedaliera Città della Salute e della Scienza
Torino, Italy
Centro Trapianti Metropolitano
Torino, Italy
Ospedale Gonzaga
Torino, Italy
UOC Ematologia
Treviso, Italy
A.O. Santa Maria della Misericordia
Udine, Italy
Policlinico GB Rossi
Verona, Italy
Ospedale S. Bortolo-Divisione Ematologia
Vicenza, Italy
Related Publications (1)
Girmenia C, Bertaina A, Piciocchi A, Perruccio K, Algarotti A, Busca A, Cattaneo C, Raiola AM, Guidi S, Iori AP, Candoni A, Irrera G, Milone G, Marcacci G, Scime R, Musso M, Cudillo L, Sica S, Castagna L, Corradini P, Marchesi F, Pastore D, Alessandrino EP, Annaloro C, Ciceri F, Santarone S, Nassi L, Farina C, Viscoli C, Rossolini GM, Bonifazi F, Rambaldi A; Gruppo Italiano Trapianto di Midollo Osseo (GITMO) and Associazione Microbiologi Clinici Italiani (AMCLI). Incidence, Risk Factors and Outcome of Pre-engraftment Gram-Negative Bacteremia After Allogeneic and Autologous Hematopoietic Stem Cell Transplantation: An Italian Prospective Multicenter Survey. Clin Infect Dis. 2017 Nov 13;65(11):1884-1896. doi: 10.1093/cid/cix690.
PMID: 29020286DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corrado Girmenia, MD
Policlinico Umberto I - Rome
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2014
First Posted
March 17, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
August 20, 2021
Record last verified: 2021-08