Text Size

Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Ospedale Santa Croce-Carle Cuneo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier:
NCT00838643
First received: February 5, 2009
Last updated: February 6, 2009
Last verified: February 2009
History of Changes
  Purpose

Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.


Condition
Hematological Diseases
Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Invasive Aspergillosis in Allogeneic Stem Cell Transplantation Patients: an Italian Prospective Multicentre Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • Incidence of invasive aspergillosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: May 2002
Estimated Study Completion Date: December 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Allogeneic pts
Adult allogeneic HSCT recipients

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients given allogeneic HSCT in tertiary care centers or university hospitals in Piedmont

Criteria

Inclusion Criteria:

  • Age > 16 years
  • Allogeneic HSCT for a haematological disease
  • Written informed consent to the study

Exclusion Criteria:

  • Pediatric patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838643

Locations
Italy
Azienda Sanitaria Ospedaliera santa Croce e Carle
Cuneo, Italy, 12100
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
  More Information

No publications provided

Responsible Party: Nicola Mordini, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier: NCT00838643     History of Changes
Other Study ID Numbers: Gal-01
Study First Received: February 5, 2009
Last Updated: February 6, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale Santa Croce-Carle Cuneo:
allogeneic transplantation
Invasive aspergillosis

Additional relevant MeSH terms:
Aspergillosis
Hematologic Diseases
Mycoses

ClinicalTrials.gov processed this record on May 23, 2013