Procalcitonin for Predicting Serious Bacterial Infection... | NCT00800488

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

NCT00800488

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

2,209Actual

Phase

Not provided

Conditions

Fever
Bacterial Infection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Nov 24, 2008

First Submission Date that Met QC Criteria

Dec 1, 2008

First Posted Date

Dec 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,209Actual

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Days

Maximum Age

3 Months

Standard Ages

Child

Study Population

children 7 days older to 3 month older with fever

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent GAJDOS, MD	Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Emergency Depatment - Hôpital Antoine Béclère		Clamart	Hauts-de-Seine	92140	France

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001423	Bacterial Infections and Mycoses

Browse Leaves

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Browse Branches

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