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

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ClinicalTrials.gov Identifier: NCT01669005
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Neutropenia

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 : November 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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

Biospecimen Retention:   Samples With DNA
3 ml of EDTA-blood

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Andrej Trampuz, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01669005     History of Changes
Other Study ID Numbers: EK 324/06
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

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

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