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

NCT ID: NCT01669005

Last Updated: 2012-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Neutropenia

Keywords

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neutropenia multiplex PCR infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Andrej Trampuz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrej Trampuz, MD

Role: STUDY_DIRECTOR

University Hospital Lausanne, Switzerland

Christina Orasch, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Lausanne, Switzerland

Other Identifiers

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EK 324/06

Identifier Type: -

Identifier Source: org_study_id