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Usefulness of C-reactive Protein Testing in Acute Cough

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01794819
Enrollment
179
Registered
2013-02-20
Start date
2010-01-31
Completion date
2010-04-30
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infections

Keywords

antibiotics, primary care, radiology/radiography, respiratory tract infections

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.

Interventions

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.

Sponsors

University of Tromso
CollaboratorOTHER
Northern State Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the antibiotic prescribing ratewithin the first 2 weeks after first consultation

Secondary

MeasureTime frame
referral to radiographywithin the first 2 weeks after first consultation

Other

MeasureTime frameDescription
rate of recovery at the follow-up consultationwithin the first 2 weeks after first consultationRate 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026