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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01159470
Other study ID # 472010.ctil
Secondary ID
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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center
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