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

NCT00692848 | Completed

• 1 other identifier: URG73
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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

Conditions

Procalcitonin; Fever Without Source; Bacterial Infection; Bacteremia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations

Secondary Outcomes (2)

• Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)

• Procalcitonin sensitivity and specificity

Study Arms (2)

PCT+

EXPERIMENTAL

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)

PCT-

NO INTERVENTION

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.

Interventions

Procalcitonin dosage PCT-Q test (Brahms, Germany) OTHER

Procalcitonin result available to the attending physician

Also known as: PCT-Q test (Brahms, Germany)

PCT+

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 1-36 months
• With rectal temperature \>38.0 C
• And no identified source of infection after history and physical examination

You may not qualify if:

• acquired or congenital immunodeficiency

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine Emergency Department

Montreal, Quebec, H3T1L7, Canada

Location

MeSH Terms

Conditions

Bacterial Infections; Bacteremia; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sergio Manzano, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: June 6, 2008

Record last verified: 2008-06

Locations

CA (1)