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.