Healthy and Acutely Ill Children & AdultsNCT01667172
Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices in Comparison With Laboratory CRP Testing.
A study testing Point-of-Care C Reactive Protein measurement on capillary blood in people with Healthy and Acutely Ill Children & Adults, run by KU Leuven at 3 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy and Acutely Ill Children & Adults
- What is being tested?
- Point-of-Care C Reactive Protein measurement on capillary blood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesBelgium
- Study dates
- Apr 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- children: aged 1 month to 14 years
- adults: aged 18-65 years
Who cannot join
- children and adults not understanding Dutch language
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Huisartspraktijken
Leuven, Vlaams-Brabant, 3000
Medisch Centrum voor Huisartsen
Leuven, Vlaams-Brabant, 3000
UZ Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices
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:
- Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
- 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
- Being tested
- Point-of-Care C Reactive Protein measurement on capillary blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care C Reactive Protein measurement on capillary bloodDevice
capillary blood fingerstick method to determine C Reactive Protein level in the blood
| Study group | Role | What they receive |
|---|---|---|
| point-of-care test for CRP | Other | Not described Receives: Device: Point-of-Care C Reactive Protein measurement on capillary blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical accuracy
correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy and Acutely Ill Children & AdultsStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Verbakel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667172
- Sponsor's protocol ID
- S54271
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21653621Van 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.
PubMed 20132979
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices
- ClinicalTrials.gov ID
- NCT01667172
- Acronym / sponsor ID
- S54271
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| point-of-care test for CRP | Other | Device: Point-of-Care C Reactive Protein measurement on capillary blood |
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- children: aged 1 month to 14 years
- adults: aged 18-65 years
Key exclusion criteria (1 listed)
- children and adults not understanding Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care C Reactive Protein measurement on capillary bloodcapillary blood fingerstick method to determine C Reactive Protein level in the blood | Device | point-of-care test for CRP |
Primary outcome
technical accuracy
Time frame: 3 months
correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory
3 secondary outcomes
User-friendliness
Time frame: 3 months
Inter-device variability
Time frame: 3 months
Inter-observer variability
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- Background: PubMed 21653621Van 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.
- Background: PubMed 20132979Van 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-Care C Reactive Protein measurement on capillary blood in people with Healthy and Acutely Ill Children & Adults, run by KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical accuracy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01667172, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.