Usefulness of C-reactive Protein Testing in Acute Cough

NCT01794819 | Completed

• 1 other identifier: CRP-ARK-01/10
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

antibiotics; primary care; radiology/radiography; respiratory tract infections

Outcome Measures

Primary Outcomes (1)

• the antibiotic prescribing rate

  within the first 2 weeks after first consultation

Secondary Outcomes (1)

• referral to radiography

  within the first 2 weeks after first consultation

Other Outcomes (1)

• rate of recovery at the follow-up consultation

  within the first 2 weeks after first consultation

Study Arms (1)

C-reactive protein test

EXPERIMENTAL

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

Interventions

C-reactive protein test 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.

Also known as: The Afinion test system (Axis Shield)

C-reactive protein test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• an inability to fill out study documentation,
• being previously included in the study,
• immunocompromised status (HIV patients, immunosuppressive treatment),
• ongoing treatment with oral corticosteroids

Sponsors & Collaborators

• Northern State Medical University: lead
• University of Tromso: collaborator

Study Sites (1)

Northern State Medical University

Arkhangelsk, 163000, Russia

Location

Related Publications (2)

• 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.

  PMID: 36250577 DERIVED

• 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.

  PMID: 24886066 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Hasse Melbye, PhD

  University of Tromsø, Department of Community Medicine

  STUDY CHAIR

• Elena A Andreeva, MD, MPH

  Northern State Medical University, Family Medicine Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2013
• First Posted: February 20, 2013
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

RU (1)