CRP study: The value of C-reactive protein (CRP) testing in acutely ill childre

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Infections and Infestations

• Registration Number: ISRCTN69736109
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-22
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Participant/parent or guardian is willing and able to give informed consent for participation in the study.
2. Male or Female, aged 1 month to 16 years.
3. Presenting to out-of-hours with an acute illness of a maximum of 5 days.
4. A subset of children, i.e. Those with a body temperature >=38°C, will be randomised to CRP or no CRP testing.

Exclusion Criteria

1. Acute trauma
2. Clinically unstable warranting immediate care
3. Prior inclusion in the study
4. Prior inclusion in another clinical trial of an investigational medicinal product in the last 90 days or any other research in the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment Rate; Timepoints: Recruitment rate of children to the study over the length of the trial, approximately 6 months.

Secondary Outcome Measures

Name	Time	Method
1. Difference in antibiotic prescription rates. <br>2. Difference in referrals. <br>3. Difference in additional testing rates. <br>4. Difference in hospital admission. <br>5. Acceptability of the blood test by children and their parents/guardians. <br>6. Feasibility of the blood test by a nurse. <br>7. Impact of the blood test on the GPs diagnostic certainty. <br>8. Impact of the vital signs measurements applied on percentiles and prediction score on GPs diagnostic certainty.