Usefulness of C-reactive Protein Testing in Acute Cough
Primary Purpose
Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
C-reactive protein test
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Tract Infections focused on measuring antibiotics, primary care, radiology/radiography, respiratory tract infections
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
Sites / Locations
- Northern State Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-reactive protein test
Arm Description
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.
Outcomes
Primary Outcome Measures
the antibiotic prescribing rate
Secondary Outcome Measures
referral to radiography
Full Information
NCT ID
NCT01794819
First Posted
February 16, 2013
Last Updated
February 16, 2013
Sponsor
Northern State Medical University
Collaborators
University of Tromso
1. Study Identification
Unique Protocol Identification Number
NCT01794819
Brief Title
Usefulness of C-reactive Protein Testing in Acute Cough
Official Title
The Usefulness of Point-of-care-testing for C-reactive Protein in Lower Respiratory Tract Infection or Acute Cough
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern State Medical University
Collaborators
University of Tromso
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
antibiotics, primary care, radiology/radiography, respiratory tract infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-reactive protein test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
C-reactive protein test
Other Intervention Name(s)
The Afinion test system (Axis Shield)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the antibiotic prescribing rate
Time Frame
within the first 2 weeks after first consultation
Secondary Outcome Measure Information:
Title
referral to radiography
Time Frame
within the first 2 weeks after first consultation
Other Pre-specified Outcome Measures:
Title
rate of recovery at the follow-up consultation
Description
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.
Time Frame
within the first 2 weeks after first consultation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasse Melbye, PhD
Organizational Affiliation
University of Tromsø, Department of Community Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elena A Andreeva, MD, MPH
Organizational Affiliation
Northern State Medical University, Family Medicine Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern State Medical University
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
36250577
Citation
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.
Results Reference
derived
PubMed Identifier
24886066
Citation
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.
Results Reference
derived
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Usefulness of C-reactive Protein Testing in Acute Cough
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