Prospective Survey of CMV, Herpesviruses Infections and Diseases in Allo-HSCT
NCT ID: NCT04412811
Last Updated: 2025-01-06
Study Results
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Basic Information
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COMPLETED
1310 participants
OBSERVATIONAL
2021-01-01
2023-03-31
Brief Summary
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Detailed Description
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Allogeneic haematopoietic stem cell transplantation patients continue to be one of the highest risk categories for developing viral infections. Cytomegalovirus infection is the leading viral cause of morbidity and mortality and HHV6 and EBV are other major causes of complications in transplant. The risk of these infections is directly related to the type of transplant.
A better and continuous monitoring of Cytomegalovirus and other herpesviruses complication in this setting would contribute to a better knowledge of the evolving epidemiology and would lead to a better use of diagnostic strategies and of preventive and therapeutic measures.
This study is aimed to identify epidemiological characteristics of allogeneic haematopoietic stem cell transplantation patients developing cytomegalovirus and other herpesviruses infections, risk factors, diagnostic peculiarities and factors that may guide to pre-emptive therapy versus prophylaxis strategies.
Virological monitoring and health care resources utilization in Allogeneic haematopoietic stem cell transplantation recipients according to the different risk of viral infection will be also assessed. This prospective analysis will provide useful information for local clinicians to define tailored antiviral strategies in line with the change of transplantation procedures.
All consecutive patients submitted to allogeneic haematopoietic stem cell transplantation will be prospectively monitored for Cytomegalovirus Cytomegalovirus, Herpesvirus human 6 and Virus Epstein-Barr infections and diseases during the six months from transplant, because most of viral infections and diseases occur within this period after transplant. Risk factors, incidence and prognostic factors of each viral infection and disease, as well as diagnostic and therapeutic strategies employed in the various transplant centers, will be evaluated in the overall population and in subpopulations according to different transplant characteristics.
The incidence of these infections and diseases will be also collected and described according to the different types of transplant and underlying disease conditions.
The Secondary Objectives are:
To assess the factors that may affect the incidence and the prognosis of allogeneic haematopoietic stem cell transplantation infections and diseases, as well as of Herpesvirus human 6 and Virus Epstein-Barr infections and related diseases To assess the impact of allogeneic haematopoietic stem cell transplantation infections and diseases on the overall and attributable mortality at 12 months from the transplant To describe the virological diagnostic strategies of allogeneic haematopoietic stem cell transplantation, Herpesvirus human 6 and Virus Epstein-Barr infections and the allogeneic haematopoietic stem cell transplantation specific immunological reconstitution tests used in the various centres To describe the antiviral strategies employed in the various centers and in the various subpopulations of transplant patients with focus on use of antiviral drugs in prophylaxis and therapy and use of allogeneic haematopoietic stem cell transplantation -specific intravenous IVIG in prophylaxis and therapy To evaluate the impact of a local strategy about use of antiviral drugs and allogeneic haematopoietic stem cell transplantation -specific IVIG in prophylaxis and therapy on the epidemiological findings, the clinical evolution of the allogeneic haematopoietic stem cell transplantation infections and diseases and on the Health Care Resources utilization (diagnostic procedures, pharmaco-utilization, hospitalization, outpatient visits).
A web system data entry will be used for this study. Data will be stored using specific e-CRFs designed by GITMO committee and includes mainly descriptive variables. Data Center will perform extensive consistency checks and issue electronic Query Forms in case of inconsistent data. Follow-up period for the evaluation of survival will be from the date of transplant until 12 months post-transplant or death. However, patients may not have 12 months follow up and if the patients are not having 12 months of observation due to lost to follow up and not due to mortality, these patients characteristics will be compared with the rest of the patients in order to ascertain there is no bias or estimate the bias.
The study will be conducted according to the principles of Good Clinical Practice, the current Italian and European laws and regulations, in agreement with the declaration of Helsinki. The protocol has been written and the study will be conducted according to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice, issued by the European Union. The responsible Local Ethical Committee approval must be obtained before starting the trial. A copy of the patient informed consent form must be submitted to the appropriate authority or committee, together with the protocol for written approval. Written approval of the protocol and informed consent by the responsible and appropriate authority or committee must be obtained prior to recruitment of patients to the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with hematological disease
Adult and children allogenic Hematopoietic stem cell transplantation recipients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Azienda Policlinico Umberto I
OTHER
Gruppo Italiano Trapianto di Midollo Osseo
OTHER
Responsible Party
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Principal Investigators
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Corrado Girmenia
Role: PRINCIPAL_INVESTIGATOR
Azienda Policlinico Umberto I
Locations
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Ospedale San Carlo
Potenza, Italy, Italy
Policlinico GB Rossi
Verona, Italy, Italy
UO Ematologia e TMO - Ospedale C. Panico
Tricase, Lecce, Italy
A.O.U. Policlinico Federico II
Napoli, Napoli, Italy
Fondazione IRCCS San Matteo
Pavia, Pavia, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona, , Italy
Ospedale Mazzoni
Ascoli Piceno, , Italy
A.O.S. G. Moscati
Avellino, , Italy
Policlinico di Bari-Ematologia con trapianti
Bari, , Italy
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, , Italy
A.O.U. Policlinico S.Orsola-Malpighi
Bologna, , Italy
Ospedale San Orsola
Bologna, , Italy
Ospedale Regionale Generale- Divisione Ematologia
Bolzano, , Italy
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia, , Italy
Azienda Sanitaria Locale Br1 Ospedale "A. Perrino
Brindisi, , Italy
CTMO PO "Businco" A.O. "G. Brotzu"
Cagliari, , Italy
Ospedale Ferrarotto
Catania, , Italy
Struttura Complessa di Ematologia, Azienda Ospedaliera Santa Croce e Carle
Cuneo, , Italy
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
Policlinico VIto Fazzi
Lecce, , Italy
AOU Integrata
Mestre, , Italy
Divisione di Ematologia - Istituto Nazionale dei Tumori
Milan, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
Modena, , Italy
Ospedale San Gerardo
Monza, , Italy
AOU S. Giovanni di Dio e Ruggi D'Aragona
Napoli, , Italy
Uoc Sit Tmo
Napoli, , Italy
UOSC Ematologia con Trapianto CSE, AORN A. Cardarelli, AORN Cardarelli
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
CTMO Osp. V. Cervello Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, , Italy
Azienda ospedaliera Universitaria di Parma
Parma, , Italy
Policlinico San Matteo
Pavia, , Italy
Ospedale S. Maria della Misericordia
Perugia, , Italy
Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
Pescara, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
Reggio Calabria, , Italy
Arciospedale S. M. Novella
Reggio Emilia, , Italy
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
Roma, , Italy
Ospedale Bambin Gesù
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Policlinico Umberto I
Roma, , Italy
Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas
Rozzano (MI), , Italy
Ospedale Moscati
Taranto, , Italy
AOU CIttà della Salute e della Scienza
Torino, , Italy
Ospedale Regina Margherita
Torino, , Italy
A.O. Santa Maria della Misericordia
Udine, , Italy
Countries
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References
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Girmenia C, Chiusolo P, Marsili G, Piciocchi A, Mico MC, Greco R, Porto G, Galaverna F, Bonifazi F, Cutini I, Malagola M, Bramanti S, Busca A, Carella AM, Carotti A, Iori AP, Onida F, Bono R, Terruzzi E, Vacca A, Rinaldi A, Cavattoni IM, Picardi A, Faraci M, Lazzarotto T, Baldanti F, Clerici P, Castagna L, Martino M, Ciceri F. The Changing Impact of Human Cytomegalovirus Serology and Infection on Patient Outcome After Allogeneic Hematopoietic Stem Cell Transplantation: An Italian Prospective Multicenter Survey in the Era of Letermovir Prophylaxis. Open Forum Infect Dis. 2025 Apr 18;12(5):ofaf233. doi: 10.1093/ofid/ofaf233. eCollection 2025 May.
Other Identifiers
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CYTOALLO GITMO-AMCLI SURVEY
Identifier Type: -
Identifier Source: org_study_id
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