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

NCT ID: NCT01159470

Last Updated: 2010-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Bacterial Infections; Viral Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

bacterial infection

children with fever due to bacterial infection

No interventions assigned to this group

viral infection

children with fever due to viral infection

No interventions assigned to this group

Eligibility 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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shaare-Zedek Medical Center

Other Identifiers

472010.ctil

Identifier Type: -

Identifier Source: org_study_id