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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia

ClinicalTrials.gov processed this record on November 23, 2014