Back to resultsImpact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Primary Purpose
Procalcitonin, Fever Without Source, Bacterial Infection
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Procalcitonin dosage PCT-Q test (Brahms, Germany)
Sponsored by
About this trial
This is an interventional diagnostic trial for Procalcitonin focused on measuring Procalcitonin, Antibiotic, Fever without source, Fever without focus, bacteremia, Urinary tract infection
Eligibility Criteria
Inclusion Criteria:
- Children 1-36 months
- With rectal temperature >38.0 C
- And no identified source of infection after history and physical examination
Exclusion Criteria:
- acquired or congenital immunodeficiency
Sites / Locations
- CHU Sainte-Justine Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PCT+
PCT-
Arm Description
Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm procalcitonin result is revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him
Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm, procalcitonin is not revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him.
Outcomes
Primary Outcome Measures
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations
Secondary Outcome Measures
Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
Procalcitonin sensitivity and specificity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00692848
Brief Title
Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Official Title
The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Serious bacterial infections are often difficult to detect in children with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procalcitonin, Fever Without Source, Bacterial Infection, Bacteremia
Keywords
Procalcitonin, Antibiotic, Fever without source, Fever without focus, bacteremia, Urinary tract infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCT+
Arm Type
Experimental
Arm Description
Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm procalcitonin result is revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him
Arm Title
PCT-
Arm Type
No Intervention
Arm Description
Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm, procalcitonin is not revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him.
Intervention Type
Other
Intervention Name(s)
Procalcitonin dosage PCT-Q test (Brahms, Germany)
Other Intervention Name(s)
PCT-Q test (Brahms, Germany)
Intervention Description
Procalcitonin result available to the attending physician
Primary Outcome Measure Information:
Title
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations
Secondary Outcome Measure Information:
Title
Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
Title
Procalcitonin sensitivity and specificity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 1-36 months
With rectal temperature >38.0 C
And no identified source of infection after history and physical examination
Exclusion Criteria:
acquired or congenital immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Manzano, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine Emergency Department
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1L7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
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