Clinical Trials Directory

Trials / Completed

CompletedNCT00800488

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
2,209 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
7 Days – 3 Months
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2008-10-01
Primary completion
2011-02-01
Completion
2011-04-01
First posted
2008-12-02
Last updated
2014-07-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00800488. Inclusion in this directory is not an endorsement.