C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting (CRP)
Efficacy of Point-of-care (POC) C-reactive Protein Testing to Reduce Inappropriate Use of Antibiotics for Acute Respiratory Infections (ARIs) in the Primary Health Care Setting of Hanoi - a Randomized Controlled Trial
Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence of antibiotic abuse for community acute respiratory infection has been reported. This study will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory illness at primary healthcare stations reduces inappropriate antibiotic use safely.
The study will be conducted at ten district health care facilities in Hanoi, Viet Nam. Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute respiratory infection. Patients will be randomly allocated to the control or the intervention arm. Participants in the control group will be treated according to routine care. Participants in the intervention arm will have a CRP test, the results of which will be available to the health care practitioner to contribute to their diagnosis and treatment decisions.
All patients will be followed-up via telephone call after 14 days. The study will compare the proportion of patients in each arm receiving any antibiotics within 2 weeks of study enrollment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Hanoi, Vietnã, 10000
- National Hospital for Tropical Diseases
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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, aged 6 to 65 years, that visit one of the 10 selected primary healthcare centers
- Suspected to have acute respiratory tract infection (ARI) by treating physician
- Informed consent
Exclusion Criteria:
- Severe respiratory disease as determined by treating doctor
- Any disease or symptom requiring hospital referral as determined by treating doctor
- Immunosuppressed patients (e.g. HIV, long term steroid use)
- Suspicion of tuberculosis
- Evidence of acute or chronic liver disease (e.g. hepatitis or cirrhosis due to any cause)
- Past medical history of: neoplastic disease, congestive cardiac failure, chronic obstructive pulmonary disease, insulin-dependent diabetes or renal disease
- Pregnancy
- No access to telephone
- Not able to come for follow up visit on day 3 or 4.
- Already taking antibiotics at the time of presentation
- Symptoms present for more than 2 weeks
- Presence of any sign of severe diseases as defined by the British Thoracic Society modified CRP-65 system for severity scoring of pneumonia in primary care.
For children (Age ≥ 6 years and < 16 years) additional exclusion criteria include: Tachypnea, signs of chest wall in drawing, reduced consciousness, confusion, dehydration, hypothermia, severe malnutrition, unable to feed or drink, vomiting, and convulsions.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: CRP intervention
Patients will be tested by rapid POC CRP test
|
Patient will be tested with CRP test.
Treatment decisions including any antibiotics prescribed will be based on test results and clinical judgement.
Treatment choices are not recommended/prescribed by the study protocol.
|
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Sem intervenção: Control
Patients will not be tested by rapid POC CRP test
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of patients receiving any antibiotic
Prazo: 2 weeks
|
Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients.
|
2 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of symptoms
Prazo: 2 weeks
|
Number of days that symptoms (including fever or any respiratory symptom) endure.
|
2 weeks
|
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Frequency of re-consultation
Prazo: 2 weeks
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Number of visits to a health care practitioner during the 14 day follow-up.
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2 weeks
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Frequency of serious adverse events
Prazo: 2 weeks
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Number of serious adverse events which occur during the 14 day follow-up period.
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2 weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The attitudes and satisfaction of patients and health center staff towards the test.
Prazo: 2 weeks
|
Patients and health center staff will be interviewed by structured questionnaire to assess their attitudes and satisfaction toward the intervention. The Likert scale will be used for quantifying attitude orientation of interviewees |
2 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Heiman FL Wertheim, M.D,Ph.D, Oxford University Clinical Research Unit
Publicações e links úteis
Publicações Gerais
- Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9.
- Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 05HN
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