Usefulness of C-reactive Protein Testing in Acute Cough

NCT ID: NCT01794819

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-04-30

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

C-reactive protein test

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

The Afinion test system (Axis Shield)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

Northern State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hasse Melbye, PhD

Role: STUDY_CHAIR

University of Tromsø, Department of Community Medicine

Elena A Andreeva, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northern State Medical University, Family Medicine Department

Locations

Northern State Medical University

Arkhangelsk, , Russia

Countries

Russia

References

Smedemark SA, Aabenhus R, Llor C, Fournaise A, Olsen O, Jorgensen KJ. Biomarkers as point-of-care tests to guide prescription of antibiotics in people with acute respiratory infections in primary care. Cochrane Database Syst Rev. 2022 Oct 17;10(10):CD010130. doi: 10.1002/14651858.CD010130.pub3.

Reference Type: DERIVED

PMID: 36250577 (View on PubMed)

Andreeva E, Melbye H. Usefulness of C-reactive protein testing in acute cough/respiratory tract infection: an open cluster-randomized clinical trial with C-reactive protein testing in the intervention group. BMC Fam Pract. 2014 May 2;15:80. doi: 10.1186/1471-2296-15-80.

Reference Type: DERIVED

PMID: 24886066 (View on PubMed)

Other Identifiers

CRP-ARK-01/10

Identifier Type: -

Identifier Source: org_study_id