Skip to main content
OpenTrials
Completed

NCT Number: NCT00800488

Procalcitonin for Predicting Serious Bacterial Infection in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fever Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Body Temperature Changes Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Emergency Depatment - Hôpital Antoine Béclère

Clamart, Hauts-de-Seine, 92140, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PRONOUR

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2008
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.