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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00800488
First received: November 24, 2008
Last updated: July 25, 2014
Last verified: April 2011

November 24, 2008
July 25, 2014
October 2008
February 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00800488 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
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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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

children 7 days older to 3 month older with fever

  • Fever
  • Bacterial Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2209
April 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00800488
AOR 06 047
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Vincent GAJDOS, MD Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
Assistance Publique - Hôpitaux de Paris
April 2011

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