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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hanoi、越南、10000
- National Hospital for Tropical Diseases
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CRP intervention
Patients will be tested by rapid POC CRP test
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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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无干预：Control
Patients will not be tested by rapid POC CRP test
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients receiving any antibiotic
大体时间：2 weeks
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Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients.
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2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration of symptoms
大体时间：2 weeks
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Number of days that symptoms (including fever or any respiratory symptom) endure.
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2 weeks
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Frequency of re-consultation
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The attitudes and satisfaction of patients and health center staff towards the test.
大体时间：2 weeks
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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
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合作者和调查者
调查人员
- 研究主任：Heiman FL Wertheim, M.D,Ph.D、Oxford University Clinical Research Unit
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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