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

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Completed
CT.gov ID
NCT01669005
Collaborator
University Hospital, Basel, Switzerland (Other)
84
Enrollment
13
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    84 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      No locations specified.

      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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Andrej Trampuz, MD, Centre Hospitalier Universitaire Vaudois
      ClinicalTrials.gov Identifier:
      NCT01669005
      Other Study ID Numbers:
      • EK 324/06
      First Posted:
      Aug 20, 2012
      Last Update Posted:
      Aug 20, 2012
      Last Verified:
      Aug 1, 2012
      Keywords provided by Andrej Trampuz, MD, Centre Hospitalier Universitaire Vaudois
      neutropenia
      multiplex PCR
      infection
      Additional relevant MeSH terms:
      Neutropenia

      Study Results

      No Results Posted as of Aug 20, 2012