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

This study has been completed.
Sponsor:
Information provided by:
St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00692848
First received: June 4, 2008
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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 Intervention
Procalcitonin
Fever Without Source
Bacterial Infection
Bacteremia
Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection) [ Designated as safety issue: No ]
  • Procalcitonin sensitivity and specificity [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: November 2006
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   1 Month to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692848

Locations
Canada, Quebec
CHU Sainte-Justine Emergency Department
Montreal, Quebec, Canada, H3T1L7
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Sergio Manzano, MD St. Justine's Hospital
  More Information

No publications provided

Responsible Party: Sergio Manzano MD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00692848     History of Changes
Other Study ID Numbers: URG73
Study First Received: June 4, 2008
Last Updated: June 5, 2008
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Procalcitonin
Antibiotic
Fever without source
Fever without focus
bacteremia
Urinary tract infection

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Fever
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014