Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months (PRONOUR)

Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months

The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.

2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.

Evaluation of the area under the ROC for Procalcitonin concentration.

Study Overview

• Status: Completed
• Conditions: Fever; Bacterial Infection

Detailed Description

Serious bacterial infections are often difficult to detect in infant 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 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

• Study Type: Observational
• Enrollment (Actual): 2209

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Clamart, Hauts-de-Seine, France, 92140
      • Pediatric Emergency Depatment - Hôpital Antoine Béclère

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children 7 days older to 3 month older with fever

Description

Inclusion Criteria:

• Infant older than 7 days old and less than 3 months old.
• Fever (defined by a rectal temperature greater than or equal to 38°C)
• Emergency consultation

Exclusion Criteria:

• Infants with a previously identified immunodeficiency or chronic disease,
• Antibiotic treatment within the previous 48 hours

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections	At the day of emergency consultation for fever

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin	At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin	At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of CRP versus procalcitonin	At the day of emergency consultation for fever

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Vincent GAJDOS, MD, Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: December 1, 2008
• First Posted (Estimate): December 2, 2008

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Fever; Procalcitonin; Infant; Serious Bacterial Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: AOR 06 047