Fever Clinical Trial
— PRONOUROfficial title:
Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months
Verified date | April 2011 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2209 |
Est. completion date | April 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 3 Months |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Pediatric Emergency Depatment - Hôpital Antoine Béclère | Clamart | Hauts-de-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin | At the day of emergency consultation for fever | No | |
Secondary | Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin | At the day of emergency consultation for fever | No | |
Secondary | Diagnostic value (sensibility and specificity) of CRP versus procalcitonin | At the day of emergency consultation for fever | No |
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