An interventional study of C-reactive protein test in Respiratory Tract Infections, sponsored by Northern State Medical University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-20.
Sponsored by Northern State Medical University · Not applicable, Interventional, and Diagnostic
The aim of this study is to evaluate the usefulness in Russian general practice of C-reactive protein testing in patients with acute cough or lower respiratory tract infections.
In addition to studying the effect of C-reactive protein testing on the prescription of antibiotics, the purpose is to find out whether the frequency of referral to radiography could be reduced.
Eighteen general practitioners, from both urban and rural offices, were randomised into intervention and control groups. All registrations were made by general practitioners in their offices.
The case report form was similar to that used in the GRACE study (Genomics to combat Resistance against Antibiotics in Community-acquired lower respiratory tract infections in Europe (www.grace-lrti.org) describing symptoms, findings, and treatment in lower respiratory tract infections.
The C-reactive protein test was performed in the intervention group at both the first and second consultations. The Afinion test system was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis.
General practitioners could prescribe any treatment, including antibiotics and other drugs for the cough and additional medication if deemed necessary.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 179 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Northern State Medical University is the lead sponsor of 23 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The C-reactive protein test was performed in the intervention group at both the first and second consultations. The Afinion test system (Axis Shield) was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis. The measurement range in whole blood samples is 8-200 mg/L.
Device: C-reactive protein test
Results provides within 5 minutes. This test is based on solid-phase sandwich immunometric analysis. The measurement range in whole blood samples is 8-200 mg/L.
Also known as: The Afinion test system (Axis Shield)
the antibiotic prescribing rate
Time frame: within the first 2 weeks after first consultation
referral to radiography
Time frame: within the first 2 weeks after first consultation
rate of recovery at the follow-up consultation
Rate of recovery at the follow-up consultation after 2 weeks with the following five alternatives: "fully recovered", "almost recovered", "slightly improved", "unchanged", and "worse". Consultations with the general practitioner within 2 weeks and complications (in need of hospitalisation) were recorded.
Time frame: within the first 2 weeks after first consultation
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Northern State Medical University