Usefulness of C-reactive Protein Testing in Acute Cough
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|ClinicalTrials.gov Identifier: NCT01794819|
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : February 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infections||Device: C-reactive protein test||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Usefulness of Point-of-care-testing for C-reactive Protein in Lower Respiratory Tract Infection or Acute Cough|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: 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.
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.
Other Name: The Afinion test system (Axis Shield)
- the antibiotic prescribing rate [ Time Frame: within the first 2 weeks after first consultation ]
- referral to radiography [ Time Frame: within the first 2 weeks after first consultation ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794819
|Northern State Medical University|
|Arkhangelsk, Russian Federation, 163000|
|Study Chair:||Hasse Melbye, PhD||University of Tromsø, Department of Community Medicine|
|Principal Investigator:||Elena A Andreeva, MD, MPH||Northern State Medical University, Family Medicine Department|