The Impact of C-reactive Protein Testing on Antibiotic Prescription in Febrile Patients Attending Primary Care in Low-resource Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,410
- 试验地点
- 2
- 主要终点
- The proportion of recruited patients prescribed an antibiotic
研究概览
简要总结
PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC) testing on health care worker prescribing behaviour in patients presenting to primary healthcare centres with an acute fever or recent history of fever.
SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14 days of follow-up.
To assess the correlation between CRP results and clinical outcomes on the day 5 of the enrolment.
To estimate the impact of CRP testing on antibiotic consumption after first consultation.
To explore the attitudes of health centre staff towards the POC CRP test. To identify the prevalence of key pathogens in febrile patients in these settings.
To validate the ability of CRP to discriminate between viral and bacterial pathogens in a subset of patients with a microbiologically confirmed diagnosis.
详细描述
This is a multi-centre, individually randomized-controlled, three-armed pragmatic trial comparing CRP guided antibiotic prescription in febrile patients to the current standard prescribing systems. The study will be implemented in low and middle-income countries in tropical settings, including Myanmar and Thailand in the first instance.
As participation in the study itself may raise awareness amongst the health centre staff and local community, current antibiotic prescribing rates will be assessed in an observational run-in period before the intervention. Health workers will be asked to complete case record forms (CRF) for patients presenting to their health centre with current or recent fever. This aims to capture current antibiotic prescribing habits before the study is launched.
During the intervention phase, patients fulfilling the inclusion criteria and who consent to participate in the study will be randomised to one of the three arms, as follows:
- Control group: The health care provider will manage the patient using standard guidelines. No CRP will be measured onsite
- Group A: CRP will be measured by a study nurse and the result will be communicated to the health care provider as "High-CRP" or "Low-CRP" using a low CRP cut-off of 20mg/L.
- Group B: CRP will be measured by a study nurse and the result will be communicated to the health care provider as "High-CRP" or "Low-CRP" using the higher CRP cut-off, of 40mg/L.
For the two intervention arms, the following guidance will be given to the health care provider: if the CRP test is reported as 'high', antibiotic treatment is recommended, following local guidelines, and if it is reported as 'low' antibiotics are not recommended. In either case the information provided by the CRP test should be interpreted alongside their clinical judgement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥1 year presenting to selected primary healthcare centres
- •Tympanic temperature >37.5°c or history of fever ≤ 14 days.
排除标准
- •Patients that in view of the study nurse are in need of emergency referral to a higher-level facility, as indicated by either 1) impaired consciousness or 2) inability to take oral medication.
- •In sites that routinely test for malaria, patients with a positive malaria rapid diagnostic test or microscopy will be excluded
- •The main complaint is a trauma and/or injury
- •Suspicion of tuberculosis (any medical history and/or physical examination suggesting tuberculosis)
- •Suspicion of Urinary Tract Infections (any medical history and/or physical examination suggesting urinary tract infections)
- •Suspicion of local skin/dental abscess (any medical history and/or physical examination suggesting a local skin/dental abscess
- •Any presenting symptom present for more than 14 days
- •Bleeding, including otorrhagia, haematemesis, haemoptysis, haemorrhagic petechiae, haematuria, bloody diarrhoea.
- •Not able to comply with the follow-up at Day 5 (+ / - 1 day).
结局指标
主要结局
The proportion of recruited patients prescribed an antibiotic
时间窗: 6 Days
The proportion of recruited patients prescribed an antibiotic at the health centre on or between their enrolment and the first follow-up visit (on day 5 +/- 1 day).
次要结局
- Frequency of severe clinical outcomes(14 Days)
- The likelihood ratio (LR) of correctly identifying a bacterial infection by using CRP-testing.(6 months)
- Proportion of patients that needed their clinical management changed within the 14 days of follow-up.(14 Days)
- Frequency of unplanned re-consultation(14 Days)
- Proportion of urine samples that tested positive for presence of antibiotics(14 Days)
- The proportion of a population who have key pathogens(6 months)
- Percentage of subjects who are correctly identified as having bacterial infections by using CRP testing(6 months)
- Severity of symptoms(14 Days)
- Interview of health centre staff for attitudes and satisfaction(6 months)
- Duration of symptoms(14 Days)
- Clinical outcome on Day 5 compare to CRP level(5 Days)
- Proportion of patients with an immediate versus subsequent prescription within 2 weeks.(14 Days)
- Percentage of subjects who are correctly identified as having viral infections by using CRP testing(6 months)
- The receiver operating characteristic (ROC) for evaluating the accuracy of CRP-testing in identifying bacterial infections.(6 months)