NCT01159470

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

July 8, 2010

Last Update Submit

July 8, 2010

Conditions

Keywords

CRP velocity

Study Arms (2)

bacterial infection

children with fever due to bacterial infection

viral infection

children with fever due to viral infection

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children \< 5 years of age presenting to the Emergency Department with fever

You may qualify if:

  • 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.

You may not qualify if:

  • HIV,
  • immunosuppressive conditions,
  • antibiotic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bacterial InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 9, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 9, 2010

Record last verified: 2010-07