Usefulness of C-reactive Protein Testing in Acute Cough

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794819
• Other study ID #: CRP-ARK-01/10
• Status: Completed
• Phase: N/A
• First received: February 16, 2013
• Last updated: February 16, 2013
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: February 2013
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Russian Federation	Northern State Medical University	Arkhangelsk

Sponsors (2)

Lead Sponsor	Collaborator
Northern State Medical University	University of Tromso

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of recovery at the follow-up 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.	within the first 2 weeks after first consultation	No
Primary	the antibiotic prescribing rate		within the first 2 weeks after first consultation	Yes
Secondary	referral to radiography		within the first 2 weeks after first consultation	Yes