We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00800488
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Fever Bacterial Infection

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 Design

Study Type : Observational
Actual Enrollment : 2209 participants
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
Study Start Date : October 2008
Primary Completion Date : February 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ]
  2. Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ]
  3. Diagnostic value (sensibility and specificity) of CRP versus procalcitonin [ Time Frame: At the day of emergency consultation for fever ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00800488     History of Changes
Other Study ID Numbers: AOR 06 047
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: April 2011

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs