Usefulness of C-reactive Protein Testing in Acute Cough

Not Applicable

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Device: C-reactive protein test

• Registration Number: NCT01794819
• Lead Sponsor: Northern State Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2013-02
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-16
• Last Update Submitted: 2013-02-16
• Study First Posted: 2013-02-20
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-reactive protein test	C-reactive protein test	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.

Primary Outcome Measures

Name	Time	Method
the antibiotic prescribing rate	within the first 2 weeks after first consultation

Secondary Outcome Measures

Name	Time	Method
referral to radiography	within the first 2 weeks after first consultation

Trial Locations

Locations (1)

Northern State Medical University; 🇷🇺 Arkhangelsk, Russian Federation