Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months (PRONOUR)
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Purpose
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 |
|---|
|
Fever Bacterial Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months |
- 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 ] [ Designated as safety issue: No ]
- Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]
- Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]
- Diagnostic value (sensibility and specificity) of CRP versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ] [ Designated as safety issue: No ]
| Enrollment: | 2209 |
| Study Start Date: | October 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
children 7 days older to 3 month older with fever
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
Contacts and Locations| France | |
| 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 |
More Information
No publications provided
| Responsible Party: | Aurélie GUIMFACK, Department Clinical Research of Developpement |
| ClinicalTrials.gov Identifier: | NCT00800488 History of Changes |
| Other Study ID Numbers: | AOR 06 047 |
| Study First Received: | November 24, 2008 |
| Last Updated: | April 14, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Fever Infant Procalcitonin Serious Bacterial Infection |
Additional relevant MeSH terms:
|
Bacterial Infections Fever Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013