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

This study has been completed.

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00800488

First received: November 24, 2008

Last updated: April 14, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2008

Last Updated Date

April 14, 2011

Start Date ^ICMJE

October 2008

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections [ Time Frame: At the day of diagnostic blood collection ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00800488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin [ Time Frame: At the day of diagnostic blood collection ] [ Designated as safety issue: No ]
Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin [ Time Frame: At the day of diagnostic blood collection ] [ Designated as safety issue: No ]
Diagnostic value (sensibility and specificity) of CRP versus procalcitonin [ Time Frame: At the day of diagnostic blood collection ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

children 7 days older to 3 month older with fever

Condition ^ICMJE

Fever
Bacterial Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2209

Completion Date

April 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 3 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00800488

Other Study ID Numbers ^ICMJE

AOR 06 047

Has Data Monitoring Committee

Responsible Party

Aurélie GUIMFACK, Department Clinical Research of Developpement

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vincent GAJDOS, MD

Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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