Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398775
Status:
TERMINATED
Last Update Posted:
2007-11-20
First Post:
2006-11-13
Brief Title:
Procalcitonin in Fever of Unknown Etiology
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
Procalcitonin Guided Antimicrobial Discontinuation in Hospitalised Patients With Fever of Unknown Etiology
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Antimicrobial resistance has increasingly become a threat to patient safety in health care settings1 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 outcomes2 High rates of antimicrobial use have been linked to high rates of antimicrobial resistance3 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 inappropriate7
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 decisions9 Procalcitonin covers these features better as compared to other more commonly used biomarkers such as CRP10 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
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 decisions9 Procalcitonin covers these features better as compared to other more commonly used biomarkers such as CRP10 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None