Procalcitonin in Fever of Unknown Etiology

NCT00398775 | Terminated

• 1 other identifier: 2006/36
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Fever

Keywords

procalcitonin guided antibiotic discontinuation; fever of unknown origin

Outcome Measures

Primary Outcomes (3)

• Exposure to systemic antimicrobial treatment:

• duration of antibiotic treatment (in days).

• total antibiotic exposure (in defined daily doses).

Secondary Outcomes (5)

• 28-day case-fatality rate (in %)

• Length of hospital stay (in days)

• Costs of antimicrobial therapy (in SGD)

• Rate of nosocomial super-infection (in N super-infections per 100 patients)

• Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)

Interventions

antibiotic discontinuation PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All hospitalized patients admitted to general medical or GRM wards with fever and no obvious source of infection, and
• remain febrile after 72 hours of empiric, antimicrobial therapy, and
• initial blood cultures are negative.

You may not qualify if:

• 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.
• Confirmed bacterial, viral or fungal infection (positive stain, culture or serology from appropriate clinical specimen).
• Hypotension (systolic blood pressure \<90mmHg)
• Respiratory failure (oxygen requirement \> 4L/min via nasal canula)
• Patients admitted to intensive care unit.
• Severely immunocompromised patients: (febrile neutropenia, HIV infection with CD4 count \< 200, immuno-suppressive therapy).
• Patients younger than 21.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (4)

• Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.

  PMID: 14987884 BACKGROUND

• Briel M, Christ-Crain M, Young J, Schuetz P, Huber P, Periat P, Bucher HC, Muller B. Procalcitonin-guided antibiotic use versus a standard approach for acute respiratory tract infections in primary care: study protocol for a randomised controlled trial and baseline characteristics of participating general practitioners [ISRCTN73182671]. BMC Fam Pract. 2005 Aug 18;6:34. doi: 10.1186/1471-2296-6-34.

  PMID: 16107222 BACKGROUND

• Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.

  PMID: 16603606 BACKGROUND

• Christ-Crain M, Muller B. Procalcitonin in bacterial infections--hype, hope, more or less? Swiss Med Wkly. 2005 Aug 6;135(31-32):451-60. doi: 10.4414/smw.2005.11169.

  PMID: 16208582 BACKGROUND

MeSH Terms

Conditions

Fever; Fever of Unknown Origin

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maciej P Chlebicki, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: January 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

SG (1)