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

Bacterial Infections Clinical Trial

— CRPv  

Official title:

CRP Velocity as a Marker for Bacterial Infections in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01159470
• Other study ID #: 472010.ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: July 8, 2010
• Last updated: July 8, 2010
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2010
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Viral Infection
• Virus Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center