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The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children (CRPv)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159470
First Posted: July 9, 2010
Last Update Posted: July 9, 2010
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.
Information provided by:
Shaare Zedek Medical Center
  Purpose

Fever is one of the most common problems in pediatrics. Differentiating between bacterial infections, that require antibiotic therapy, and viral infections that resolve on their own is an important challenge for physicians.

C-reactive protein (CRP) is a protein that increases in response to inflammation and its level is generally higher in bacterial infections compared to viral infections. it can be measured by a simple blood test, however its utility as a sole marker for bacterial infection is limited.

The hypothesis of the study is that measuring CRP velocity, e.g the value of CRP divided by the hours since the fever started will improve the utility of CRP for the diagnosis of bacterial infections in children.


Condition
Bacterial Infections Viral Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CRP Velocity as a Marker for Bacterial Infections in Children

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
bacterial infection
children with fever due to bacterial infection
viral infection
children with fever due to viral infection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children < 5 years of age presenting to the Emergency Department with fever
Criteria

Inclusion Criteria:

  • children less than 5 years of age,
  • children with no comorbidities and fever > 38 for at least 24 hours, and
  • children with no previous antibiotic therapy.

Exclusion Criteria:

  • HIV,
  • immunosuppressive conditions,
  • antibiotic therapy.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Maskit Bar-Meir, MD, Shaare-Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01159470     History of Changes
Other Study ID Numbers: 472010.ctil
First Submitted: July 8, 2010
First Posted: July 9, 2010
Last Update Posted: July 9, 2010
Last Verified: July 2010

Keywords provided by Shaare Zedek Medical Center:
CRP velocity

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Virus Diseases