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

Neutropenic Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034059
• Other study ID #: 200806051R
• Status: Completed
• Phase: N/A
• First received: December 16, 2009
• Last updated: December 16, 2009
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenic Fever

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital