Healthy and Acutely Ill Children & Adults Clinical Trial
Official title:
Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices
| Verified date | August 2012 |
| Source | Katholieke Universiteit Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive
Protein devices (POC CRP devices) in comparison with laboratory CRP testing on children and
adults.
Research questions:
1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP
values measured at the clinical laboratory?
2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?
2.1.1. Comparison of 2 measurements in the same patient on 1 device
(inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on
2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices
equally userfriendly in a general practice surgery? (userfriendliness
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 1 Month to 65 Years |
| Eligibility |
Inclusion Criteria: - children: aged 1 month to 14 years - adults: aged 18-65 years Exclusion Criteria: - children and adults not understanding Dutch language |
Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Huisartspraktijken | Leuven | Vlaams-Brabant |
| Belgium | Medisch Centrum voor Huisartsen | Leuven | Vlaams-Brabant |
| Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Katholieke Universiteit Leuven |
Belgium,
Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2. Review. — View Citation
Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | technical accuracy | correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory | 3 months | No |
| Secondary | User-friendliness | evaluation of the userfriendliness by General Practitioners at 5 practices, on a five point Likert-scale scoring these criteria: device start-up, test duration, sample size, test characteristics, calibration, measuring range, handling of test tubes, filling of the capillary, placing the test cartridge, test recording and additional material usage. The median results are compared between both devices qualitatively. | 3 months | No |
| Secondary | Inter-device variability | The inter-device-variability (by 1 physician) was tested on 10 patients in one General Practice surgery each on two different Point-of-Care devices of the same brand. | 3 months | No |
| Secondary | Inter-observer variability | The inter-observer variability (by two physicians) was tested on 10 patients in one GP surgery on two different Point-of-care devices of the same brand. | 3 months | No |