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
  Purpose

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.


Condition
Fever
Bacterial Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2209
Study Start Date: October 2008
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children 7 days older to 3 month older with fever

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800488

Locations
France
Pediatric Emergency Depatment - Hôpital Antoine Béclère
Clamart, Hauts-de-Seine, France, 92140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Vincent GAJDOS, MD Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00800488     History of Changes
Other Study ID Numbers: AOR 06 047
Study First Received: November 24, 2008
Last Updated: July 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fever
Infant
Procalcitonin
Serious Bacterial Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014