- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01159470
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children (CRPv)
CRP Velocity as a Marker for Bacterial Infections in Children
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
bacterial infection
children with fever due to bacterial infection
|
viral infection
children with fever due to viral infection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 472010.ctil
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