NCT01669005

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

August 16, 2012

Last Update Submit

August 17, 2012

Conditions

Neutropenia

Keywords

neutropeniamultiplex PCRinfection

Study Arms (1)

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 Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No blood samples were taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

3 ml of EDTA-blood

MeSH Terms

Conditions

NeutropeniaInfections

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Andrej Trampuz, MD

    University Hospital Lausanne, Switzerland

    STUDY DIRECTOR

  • Christina Orasch, MD

    University Hospital Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 20, 2012

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 20, 2012

Record last verified: 2012-08