Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months

NCT ID: NCT00800488

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Fever Bacterial Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

7 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent GAJDOS, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

Locations

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Pediatric Emergency Depatment - Hôpital Antoine Béclère

Clamart, Hauts-de-Seine, France

Site Status

Countries

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France

Other Identifiers

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AOR 06 047

Identifier Type: -

Identifier Source: org_study_id

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