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

NCT ID: NCT00692848

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Procalcitonin Fever Without Source Bacterial Infection Bacteremia

Keywords

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Procalcitonin Antibiotic Fever without source Fever without focus bacteremia Urinary tract infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Procalcitonin dosage PCT-Q test (Brahms, Germany)

Intervention Type OTHER

Procalcitonin result available to the attending physician

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Procalcitonin dosage PCT-Q test (Brahms, Germany)

Procalcitonin result available to the attending physician

Intervention Type OTHER

Other Intervention Names

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PCT-Q test (Brahms, Germany)

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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St. Justine's Hospital

Principal Investigators

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Sergio Manzano, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

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CHU Sainte-Justine Emergency Department

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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URG73

Identifier Type: -

Identifier Source: org_study_id