Procalcitonin and Lung Ultrasonography Point-of-care Testing to Decide on Antibiotic Prescription in Patients With Lower Respiratory Tract Infection at Primary Care Level: Pragmatic Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 469
- 试验地点
- 1
- 主要终点
- Proportion of patients prescribed an antibiotic in each arm
研究概览
简要总结
The study is randomized clustered pragmatic trial whose objective is to decrease unnecessary antibiotic prescription in adult patients with lower respiratory tract infection managed at primary care level in Switzerland, using a simple algorithm based on 2 point of care test results
详细描述
The study will have two distinct phases:
The first phase will test the feasibility of the intervention (UltraPro) along a pilot study. Following the setup of a lung ultrasound training curriculum for general practitioners, the practicality of the whole UltraPro algorithm will be evaluated at primary care level.
The second phase will be a pragmatic randomized three-arm intervention study using an algorithm based on the results of procalcitonin and lung ultrasound to manage patients with lower respiratory tract infections at primary care level. The procalcitonin-ultrasound algorithm will be compared to procalcitonin-guided management alone and usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting to a participating GP's office for a consultation for an acute respiratory infection (ARI) will be screened for inclusion in the study
- •Inclusion Criteria:
- •Informed Consent as documented by signature (Informed Consent Form)
- •Patients aged 18 years or more
- •No antibiotics prescribed for the current episode
- •Acute cough of up to 21 days duration and at least one of the following symptom or sign:
- •History of fever for more than 4 days
- •tachypnoea (≥ 22 cycles per minutes)
- •abnormal focal finding during auscultation
排除标准
- •Previous prescription of antibiotics for the current episode
- •Working diagnosis of acute sinusitis or a non-infective disorder
- •Cystic fibrosis
- •Previous episode of chronic obstructive pulmonary disease exacerbation treated with antibiotics during the last 6 months
- •Known pregnancy
- •Severe immunodeficiency (untreated HIV infection with CD4 count < 200 cells/mm3, solid organ transplant receiver, neutropenia, treatment with corticosteroids with dose equivalent to 20 mg prednisone/day for > 28
- •Admission of the patient
- •GP not available for performing study
- •Patient unable to provide informed consent
研究组 & 干预措施
UltraPro
General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm.
The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
干预措施: UltraPro (Diagnostic Test)
UltraPro
General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm.
The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
干预措施: Blood sampling (Diagnostic Test)
UltraPro
General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm.
The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
干预措施: Naso-pharyngeal swab and sputum culture (Diagnostic Test)
Procalcitonin
General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm.
The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
干预措施: Blood sampling (Diagnostic Test)
Procalcitonin
General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm.
The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
干预措施: Naso-pharyngeal swab and sputum culture (Diagnostic Test)
Usual Care
General practitioners randomly assigned to the usual care arm will be responsible to recruit patients fulfilling the inclusion criteria and will manage and treat these patients as they usually do. Only general practitioners who do not use procalcitonin and lung ultrasonography routinely will be included in the usual care arm.
Naso-pharyngeal swabs as well as sputum culture will be performed to allow for microbiologic identification of aetiological agents.
干预措施: Naso-pharyngeal swab and sputum culture (Diagnostic Test)
Procalcitonin
General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm.
The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.
干预措施: Procalcitonin (Diagnostic Test)
结局指标
主要结局
Proportion of patients prescribed an antibiotic in each arm
时间窗: Assessed at day 28 after baseline
For each arm, we will assess the proportion of patient's prescribed an antibiotic following the consultation with the general practitioner. This will be done by recording the prescription decision of the general practitioner.
次要结局
- Transcription patterns(Assessed within the first year after data collection is complete)
- Number of medical visits(Day 7 and Day 28 after baseline)
- Satisfaction of providers(Assessed at baseline)
- Satisfaction of patients(Assessed at day 7)
- Serious adverse outcome(During the first 28 days following baseline)
- Duration of algorithm completion(Assessed at baseline (Day 0))
- Aetiology of LRTIs in primary care(Assessed within the first year after data collection is complete)
- Duration of the episode(Assessed at day 28 after baseline)
- Clinical failure(Day 7 after baseline)
- Cost / effectiveness ratio(Assessed one month after data collection is complete)
- Host biomarkers(Assessed within the first year after data collection is complete)
研究者
Dr Boillat-Blanco Noemie
Principal Investigator
Centre Hospitalier Universitaire Vaudois