Clinical trial NCT01794819: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: antibiotics
primary care
radiology/radiography
respiratory tract infections
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2013-02-20
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: the antibiotic prescribing rate
timeFrame: within the first 2 weeks after first consultation
Secondary outcomes:
measure: referral to radiography
timeFrame: within the first 2 weeks after first consultation
Other outcomes:
measure: rate of recovery at the follow-up consultation
timeFrame: within the first 2 weeks after first consultation
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Northern State Medical University
Study officials:
affiliation: University of Tromsø, Department of Community Medicine
name: Hasse Melbye, PhD
role: STUDY_CHAIR
affiliation: Northern State Medical University, Family Medicine Department
name: Elena A Andreeva, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.