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

Neutropenia Clinical Trial

— MedIso  

Official title:

Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669005
• Other study ID #: EK 324/06
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: August 17, 2012
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2012
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neutropenia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	University Hospital, Basel, Switzerland