Usefulness of C-reactive Protein Testing in Acute Cough

Northern State Medical University

Status: Completed

Conditions: Respiratory Tract Infections

Treatments: Device: C-reactive protein test

Study type: Interventional

Funder types: Other

Identifiers

NCT01794819

CRP-ARK-01/10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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179 participants in 1 patient group

C-reactive protein test

Experimental group

Description:

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.

Treatment:

Device: C-reactive protein test