Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months (PRONOUR)
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|ClinicalTrials.gov Identifier: NCT00800488|
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : July 28, 2014
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.
|Condition or disease|
|Fever Bacterial Infection|
|Study Type :||Observational|
|Actual Enrollment :||2209 participants|
|Observational Model:||Case Control|
|Official Title:||Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||April 2011|
- Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections [ Time Frame: At the day of emergency consultation for fever ]
- Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ]
- Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ]
- Diagnostic value (sensibility and specificity) of CRP versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800488
|Pediatric Emergency Depatment - Hôpital Antoine Béclère|
|Clamart, Hauts-de-Seine, France, 92140|
|Principal Investigator:||Vincent GAJDOS, MD||Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère|