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Procalcitonin Guided Antimicrobial Discontinuation in Hospitalised Patients With Fever of Unknown Etiology

21 Years
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Trial Information

Procalcitonin Guided Antimicrobial Discontinuation in Hospitalised Patients With Fever of Unknown Etiology

Antimicrobial resistance has increasingly become a threat to patient safety in health care
settings.1 Several studies have identified the inappropriate use of antimicrobials as
important risk factor for antimicrobial resistance and the important area of opportunity for
increasing patient safety and improving patient outcomes.2 High rates of antimicrobial use
have been linked to high rates of antimicrobial resistance,3 and increased exposure to
antimicrobials has been associated with an increased probability of colonization with
resistant pathogens. It has also been shown that antimicrobial control results in
significant cost savings4 and it may reduce antimicrobial resistance Surveys reveal that 25
- 33% of hospitalized patients receive antibiotics6 and that 22 - 65% of antibiotic use in
hospitalized patients is inappropriate.7

Reasons for inappropriate antimicrobial therapy include:

1. treating anybody with fever (even when it is not caused by infection) with broad
spectrum antibiotics

2. treating colonization or contamination (rather than real infection)

3. continuing antibiotics even when infection was cured or is unlikely8

It is quite clear that clinicians need reliable marker for bacterial infections that would
allow an early diagnosis, inform about the course and prognosis of the disease and
facilitate therapeutic decisions.9 Procalcitonin covers these features better as compared to
other, more commonly used biomarkers (such as CRP).10 It has been shown recently that
procalcitonin guidance substantially reduces antibiotic use in community-acquired pneumonia
without compromising patients' safety. 11, 12 However, the efficacy and safety of PGAD in
hospitalized patients with undefined fever has not been previously investigated.

We think that PGAD should be equally safe and effective intervention in hospitalized
patients with fever of unknown etiology. It should help to reduce inappropriate antibiotic
use and in effect, help to control antimicrobial resistance.

Inclusion Criteria:

1. All hospitalized patients admitted to general medical or GRM wards with fever and no
obvious source of infection, and

2. remain febrile after 72 hours of empiric, antimicrobial therapy, and

3. initial blood cultures are negative.

Exclusion Criteria:

1. Patients with clinically suspected infection (strongly suggestive symptoms, signs or
laboratory/imaging studies) such as pneumonia, urinary tract infection, meningitis,
endocarditis, skin and soft tissue infection, etc.

2. Confirmed bacterial, viral or fungal infection (positive stain, culture or serology
from appropriate clinical specimen).

3. Hypotension (systolic blood pressure <90mmHg)

4. Respiratory failure (oxygen requirement > 4L/min via nasal canula)

5. Patients admitted to intensive care unit.

6. Severely immunocompromised patients: (febrile neutropenia, HIV infection with CD4
count < 200, immuno-suppressive therapy).

7. Patients younger than 21.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Exposure to systemic antimicrobial treatment:

Principal Investigator

Maciej P Chlebicki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Changi General Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

January 2007

Completion Date:

September 2007

Related Keywords:

  • Fever
  • procalcitonin guided antibiotic discontinuation
  • fever of unknown origin
  • Fever