The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies (MedIso)

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Andrej Trampuz, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01669005
First received: August 16, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.

Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia


Condition
Neutropenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Biospecimen Retention:   Samples With DNA

3 ml of EDTA-blood


Enrollment: 84
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bone marrow transplant unit patients
hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients hospitalized in the bone marrow transplant unit in the study period

Criteria

Inclusion Criteria:

  • patients aged ≥18 years
  • autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed

Exclusion Criteria:

  • No blood samples were taken
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669005

Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University Hospital, Basel, Switzerland
Investigators
Study Director: Andrej Trampuz, MD University Hospital Lausanne, Switzerland
Principal Investigator: Christina Orasch, MD University Hospital Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: Andrej Trampuz, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01669005     History of Changes
Other Study ID Numbers: EK 324/06
Study First Received: August 16, 2012
Last Updated: August 17, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
neutropenia
multiplex PCR
infection

Additional relevant MeSH terms:
Neutropenia
Hematologic Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014