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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00800488
Other study ID # AOR 06 047
Secondary ID
Status Completed
Phase N/A
First received November 24, 2008
Last updated July 25, 2014
Start date October 2008
Est. completion date April 2011

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
France Pediatric Emergency Depatment - Hôpital Antoine Béclère Clamart Hauts-de-Seine

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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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