Skip to main content
OpenTrials
Completed

NCT Number: NCT01794819

Usefulness of C-reactive Protein Testing in Acute Cough

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern State Medical University

Arkhangelsk, 163000, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: The Afinion test system (Axis Shield)

Primary outcomes

  1. the antibiotic prescribing rate

    Time frame: within the first 2 weeks after first consultation

Secondary outcomes

  1. referral to radiography

    Time frame: within the first 2 weeks after first consultation

Other outcomes

  1. rate of recovery at the follow-up consultation

    Time frame: within the first 2 weeks after first consultation

    Rate of recovery at the follow-up consultation after 2 weeks with the following five alternatives: "fully recovered", "almost recovered", "slightly improved", "unchanged", and "worse". Consultations with the general practitioner within 2 weeks and complications (in need of hospitalisation) were recorded.

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Collaborators

  • University of Tromso

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 20, 2013
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.