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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
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
Northern State Medical University

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.


Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Device: C-reactive protein test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. the antibiotic prescribing rate [ Time Frame: within the first 2 weeks after first consultation ]

Secondary Outcome Measures :
  1. referral to radiography [ Time Frame: within the first 2 weeks after first consultation ]

Other Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Russian Federation
Northern State Medical University
Arkhangelsk, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
University of Tromso
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT01794819     History of Changes
Other Study ID Numbers: CRP-ARK-01/10
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Northern State Medical University:
antibiotics
primary care
radiology/radiography
respiratory tract infections
Additional relevant MeSH terms:
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Infection
Respiratory Tract Infections
Respiratory Tract Diseases