Usefulness of C-reactive Protein Testing in Acute Cough

Study Overview
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Brief Summary
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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.

Detailed Description
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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 clinical examination included a chest examination and the axillary temperature. After the clinical examination, the general practitioners recorded their provisional diagnosis. Chest radiography was accessible for all patients. 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.

Official Title
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The Usefulness of Point-of-care-testing for C-reactive Protein in Lower Respiratory Tract Infection or Acute Cough

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Device: C-reactive protein test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with lower respiratory tract infections/acute cough (including acute bronchitis, pneumonia, and infectious exacerbations of chronic obstructive pulmonary disease or asthma), age 18 years or older, an illness of less than 28 days duration, first consultation for the illness episode, being seen in a physician's office, written consent to participate. Exclusion Criteria: an inability to fill out study documentation, being previously included in the study, immunocompromised status (HIV patients, immunosuppressive treatment), ongoing treatment with oral corticosteroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-reactive protein test<br>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<br>* 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.<br>* Other names: The Afinion test system (Axis Shield);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the antibiotic prescribing rate |  | within the first 2 weeks after first consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| referral to radiography |  | within the first 2 weeks after first consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotics, primary care, radiology/radiography, respiratory tract infections