Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source

Sponsor

St. Justine's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00692848

Collaborator

(none)

384

Enrollment

Location

Arms

Duration (Months)

20.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Procalcitonin Fever Without Source Bacterial Infection Bacteremia	Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

384 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCT+ 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	Other: Procalcitonin dosage PCT-Q test (Brahms, Germany) Procalcitonin result available to the attending physician Other Names: PCT-Q test (Brahms, Germany)
No Intervention: PCT- 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.

Arm

Intervention/Treatment

Experimental: PCT+

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

Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)

Procalcitonin result available to the attending physician

Other Names:

PCT-Q test (Brahms, Germany)

No Intervention: PCT-

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.

Outcome Measures

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 []