ISRCTN57309858已完成未知
What is the clinical and cost effectiveness of oral steroids in the treatment of acute lower respiratory tract infection (LRTI)? A placebo controlled randomised trial
niversity of Bristol (UK)0 个研究点目标入组 436 人开始时间: 2013年1月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 436
研究概览
简要总结
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25885677 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28829884 2020 economic evaluation in https://pubmed.ncbi.nlm.nih.gov/32075830/ (added 17/02/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or over
- •2. Consulting for an acute (<= 28 days) cough as the main presenting symptom
- •3. In the past 24 hours, the patient has had at least one of the screening symptoms listed below (a-d), localizing to the lower respiratory tract and suggestive of an acute lower respiratory tract infection (RTI):
- •3.1. Phlegm (sputum)
- •3.2. Chest pain
- •3.3. Shortness of breath
- •3.4. Wheeze
- •4. Patient and practice have sufficient time for consent and randomisation into the trial by the end of today
- •5. Patient able and willing to give informed consent themselves
- •6. Patient able and willing to complete the daily symptom diary themselves
- •7. Patient able and willing to receive weekly telephone calls from the trial team
排除标准
- •1. Known lung cancer or chronic lung disease (e.g. cystic fibrosis, COPD, bronchiectasis)
- •2. Has an 'active' diagnosis of asthma (for which any treatment has been given in the past 5 years)
- •3. The patient's RTI warrants same day hospital admission or immediate antibiotics (NB: use of delayed prescription does not preclude OSAC trial participation):
- •According to NICE guidelines, the patient warrants immediate antibiotic treatment by virtue of ONE OR MORE of the following:
- •1. Is clinically very unwell or has symptoms and signs suggestive of pneumonia, e.g. tachypnoea (>20bpm), unilateral chest signs or consolidation, or hypoxia (oxygen saturation <94%) or other systemic infection, e.g. suspected bacteraemia OR
- •2. Is at high risk of complications, including patients with chronic heart, chronic lung (e.g. COPD, bronchiectasis and cystic fibrosis), chronic renal, chronic liver or neuromuscular disease or immunosuppression; or with complications from previous episodes of lower respiratory tract infection, e.g. hospital admission for pneumonia OR
- •Aged over 65 years with at least TWO of the following criteria, or aged over 80 years with at least ONE of the following criteria:
- •1. Unplanned hospitalisation within the previous year
- •2. Type 1 or Type 2 diabetes
- •3. History of cardiac failure
- •4. Requires an antibiotic today to treat another infection unrelated to their acute cough, e.g. a co-existing cellulitis
- •5. Recently (<=1 month) used inhaled corticosteroids
- •6. Recently (<=1 month) used short (up to 2 weeks) course systemic corticosteroids
- •7. Currently using, or has previously (<=12 months) used systemic steroids for a cumulative period greater than 2 weeks, i.e. 'long-term' use
- •8. Known to be pregnant, is trying to conceive or is at risk of pregnancy (e.g. unwilling to take a reliable form of contraception) in the next month
- •9. Currently breast-feeding
- •10. This is not the patient's usual practice, i.e. patient is visiting or is not intending to stay with the practice for the 3 month trial follow up period
- •11. Previously randomised in the OSAC trial
- •12. Has been involved in another medicinal trial within the last 90 days or any other clinical research study within the last 30 days
- •13. Is unable to give informed consent or complete the trial paperwork (including the symptom diary) through mental incapacity, e.g. major current psychiatric illness, learning difficulties and dementia
- •14. Known immune-deficiency, e.g. chemotherapy causing immunosuppression, asplenia or splenic dysfunction, advanced cancer or HIV infection
- •15. Has any of the following known contra-indications or cautions to oral steroids current OR previous history of:
- •15.1. Peptic ulcer disease
- •15.2. Osteoporosis
- •15.3. Previous TB
- •15.4. Glaucoma
- •15.5. No previous chickenpox AND known recent (<=28 days) history of close personal contact with chickenpox OR herpes zoster
- •15.6. Suspected ocular herpes simplex
- •15.7. Cushing's disease
- •15.8. Epilepsy
- •15.9. Known allergy to prednisolone or other OS
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