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Procalcitonin in Fever of Unknown Etiology

NCT00398775 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2007-11-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether new blood test (procalcitonin) can help to reduce unnecessary use of antibiotics in patients with unexplained fever.

Although fever is most commonly caused by bacterial infection there are multiple other conditions that can cause fever. It can be caused by viral infection. It can also be caused by other non infectious disease. Patients with malignancy, inflammation (such as gout or arthritis), or clots in veins can present with fever. Occasionally medications themselves can cause fever. If fever is not caused by infection antibiotics will not help. Instead they may cause side effects such as diarrhea and allergic reactions. We want to determine whether simple blood test (procalcitonin) can help us to make a difference between fever caused by infection and fever caused by others (above mentioned) non-infectious problems. We also want to determine whether such test would help us to reduce unnecessary antibiotic use and help us to find faster the real cause of the fever.

A total of 90 patients with the unexplained fever will be participating in this study. This study will involve single, additional blood test, performed only if patient continue to have fever despite a few days of investigations and therapy with antibiotics.

Patients will be assigned by drawing to one of two groups. In the first group blood test (procalcitonin) will help a doctor to decide whether to stop or continue antibiotics. If procalcitonin level is high antibiotics will be continued and the doctor will most probably order additional tests to determine the source of infection. If procalcitonin level is low serious bacterial infection is unlikely. The antibiotics will be stopped and a doctor will try to look for other cause of fever.

In the second group blood for the tests will be collected but not reported to a doctor. You will be treated in traditional manner by a doctor.

By following this procedure we will be able to determine whether therapy guided by procalcitonin level is as safe and possibly more effective than traditional approach. This study does not involve any other tests or study medications. We will attempt to contact all patients one month later by phone to determine whether you remain well after discharge.

Conditions

Interventions

PROCEDURE

antibiotic discontinuation

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Maciej P Chlebicki, MD · Changi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2007-09-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00398775 on ClinicalTrials.gov