Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01034059
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition
Neutropenic Fever

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 75
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with hematological malignancy developing neutropenic fever after chemotherapy

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034059

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Szu-Chun Hsu, MD Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei
  More Information

No publications provided

Responsible Party: Szu-Chun Hsu, Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei
ClinicalTrials.gov Identifier: NCT01034059     History of Changes
Other Study ID Numbers: 200806051R
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Fever
Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014