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

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. Identifier: NCT01159470
Recruitment Status : Unknown
Verified July 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2010
Last Update Posted : July 9, 2010
Information provided by:
Shaare Zedek Medical Center

Brief Summary:

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 or disease
Bacterial Infections Viral Infection

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CRP Velocity as a Marker for Bacterial Infections in Children
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

bacterial infection
children with fever due to bacterial infection
viral infection
children with fever due to viral infection

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

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.

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

Keywords provided by Shaare Zedek Medical Center:
CRP velocity

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Virus Diseases