- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034059
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever
December 16, 2009 updated by: National Taiwan University Hospital
The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established biomarker useful for infection in non-neutropenic patients.
In this study, we tested sTREM-1 in the patients with neutropenic fever.
Pro-calcitonin (PCT) and C-reactive protein (CRP) were also measured.
We planned to investigate and explore the role of sTREM-1 in early diagnosis of infection in patients with neutropenic fever.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients with hematological malignancies developed neutropenia after chemotherapy.
We checked the serum level of sTREM-1 in patients with neutropenic fever.
Those patients were classified to 2 groups: documented infection or low likelihood of infection.
Their sTREM-1 level was measured and was compared with other biomarker such as CRP and procalcitonin.
The value of sTREM-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.
Study Type
Observational
Enrollment (Actual)
75
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with hematological malignancy developing neutropenic fever after chemotherapy
Description
Inclusion Criteria:
- chemotherapy-related neutropenia (granulocytes < 0.5 × 109/l or leukocytes < 1 × 109/l) and fever (body temperature > 38.0°C over a 6 hour observation period or body temperature ≥ 38.5°C once.
Exclusion Criteria:
- prolonged fever before presenting for admission,
- antibiotics therapy in the past 72 hours,
- more than two sites of infectious focus,
- concomitant solid organ malignancy and blast in hemogram.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Szu-Chun Hsu, MD, Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (Estimate)
December 17, 2009
Study Record Updates
Last Update Posted (Estimate)
December 17, 2009
Last Update Submitted That Met QC Criteria
December 16, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200806051R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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