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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 because the information has not been verified recently.
Verified July 2010 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01159470
First received: July 8, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Maskit Bar-Meir, MD, Shaare-Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01159470     History of Changes
Other Study ID Numbers: 472010.ctil
Study First Received: July 8, 2010
Last Updated: July 8, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Shaare Zedek Medical Center:
CRP velocity

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013