The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- Duration of illness and symptoms from acute respiratory tract infections.
研究概览
简要总结
Antimicrobial resistance rates have reached alarming levels and the Worlds Health Organisation (WHO) states it constitutes a serious public health concern by threatening one of the most effective and mortality lowering interventions in modern medicine. Part of the solution to this problem includes minimizing overuse of antibiotics. But clinical signs alone are often not reliable to guide antibiotic treatment decisions and additional tests may be warranted to assist the doctor. Such tests include point-of-care biomarkers of infection like C-reactive protein (CRP) and procalcitonin (PCT). Targeting antibiotic use to the few patients with a high probability of benefit and withholding in the many with non-serious respiratory infection is a promising strategy and readily implemented in clinical practice.
The Procalcitonin guided Antibiotics in Respiratory Infections (PARI) study will assess the effect of a novel point-of-care PCT guided antibiotic stewardship in acute respiratory tract infections in general practice.
The overall aim of the PARI study is to reduce antibiotic use in patients with acute respiratory tract infections by targeting antibiotic treatment only to patients with a suspected bacterial etiology and thus likely to benefit from antibiotic therapy.
The main research questions are:
Does the addition of a point-of-care Procalcitonin test to standard care reduce antibiotic use in primary care? Is the intervention safe for the patients? The PARI study is a pragmatic two-arm (intervention and control (standard care) open randomized non-inferiority trial (up to 1 day difference in recovery) in general practice.
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
- Single (Participant)
盲法说明
Procalcitonin will be measured on all participants but none of the participants will be informed about the results of the procalcitonin value or the randomisation and thus remain unaware of allocated group status (intervention or control).
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
- •Age above 18 years
- •Able to read and understand patient information about the PARI trial and willing to give written informed consent prior to enrollment
- •Acute cough e.g. less than 2 weeks probable acute upper or lower respiratory tract infection (pharyngitis, tonsillitis, otitis media, sinusitis, exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), bronchitis or pneumonia)
- •C-Reactive Protein >20 mg/m
排除标准
- •Symptoms present for more than 2 weeks
- •Verified immunodeficiency or presently neutropenic (neutrophile granulocytes ≤0,5 x 109/L within the last 7 days)
- •Severe liver failure
- •Severe kidney failure including dialysis
- •Sore throat and positive test for Group A streptococcus
- •Prior antibiotic exposure last 14 days up to inclusion
- •Need for acute admission to hospital
- •Pregnancy or breastfeeding
结局指标
主要结局
Duration of illness and symptoms from acute respiratory tract infections.
时间窗: up to 14 days
The patient reported primary outcome will be assessed as number of days to a patient's daily activities (work or recreation) are no longer restricted by symptoms from a respiratory tract infection.The non-inferiority margin between the intervention and control group is set at a one day difference. The recovery measure will be the specific day indicated by the participants using the validated Acute Respiratory Tract Infections Questionaire (ARTIQ).
次要结局
- Antibiotic treatments(1, 14 and 30 days)
- Side effects from antibiotic treatment(14 days)
- re-consultations(30 days)
- Biomarker levels(day 1)
- Severe adverse effects(30 days)
研究者
Rune Munck Aabenhus
MD. Specialist in General Practice, PhD, Assistent Professor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark