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

Completed

• Conditions: Fever; Bacterial Infection

• Registration Number: NCT00800488
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Primary Completion: 2011-02
• Status Verified: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2209

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pediatric Emergency Depatment - Hôpital Antoine Béclère; 🇫🇷 Clamart, Hauts-de-Seine, France