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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00800488

Acronym

PRONOUR

Enrollment

2209

Registered

2008-12-02

Start date

2008-10-31

Completion date

2011-04-30

Last updated

2014-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection, Fever

Keywords

Fever, Infant, Procalcitonin, Serious Bacterial Infection

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Days to 3 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin	At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin	At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of CRP versus procalcitonin	At the day of emergency consultation for fever

Countries

France

Outcome results