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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Arkhangelsk, Federação Russa, 163000
- Northern State Medical University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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. |
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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the antibiotic prescribing rate
Prazo: within the first 2 weeks after first consultation
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within the first 2 weeks after first consultation
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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referral to radiography
Prazo: within the first 2 weeks after first consultation
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within the first 2 weeks after first consultation
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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rate of recovery at the follow-up consultation
Prazo: within the first 2 weeks after first consultation
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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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within the first 2 weeks after first consultation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Hasse Melbye, PhD, University of Tromsø, Department of Community Medicine
- Investigador principal: Elena A Andreeva, MD, MPH, Northern State Medical University, Family Medicine Department
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CRP-ARK-01/10
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Ensaios clínicos em C-reactive protein test
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