Bacterial Load Guided Therapy for Severe Exacerbations of Bronchiectasis Requiring IntraVenous Antibiotic Therapy- BLT Br IV Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to next exacerbation
研究概览
简要总结
From the British Thoracic Guidelines1 and a PUBMED search there are no randomised controlled trials exploring optimum antibiotic duration for chest infections. The standard course of intravenous antibiotics for exacerbations of bronchiectasis is 14 days. This is a preliminary open labelled study to assess whether it is feasible to stop treatment earlier (day 8 or day 11) if the bacterial load is low or absent at days 7 or day 10 (it takes 24 hours for the results to be processed). All patients will therefore have a minimum of 7 days intravenous antibiotics. The intravenous antibiotic chosen is routinely used for exacerbations in bronchiectasis.
Our hypothesis is that patients could have personalised treatment and be able to stop antibiotics when the sputum bacterial load is low (<10^6 colony forming units/ml (cfu/ml)).
详细描述
We will investigate 90 patients with bronchiectasis who are developing an exacerbation as defined by the British Thoracic Society guidelines requiring intravenous antibiotics.
After being consented, patients will be randomly allocated to one of two arms (computer generated). 45 patients will have length of treatment guided by the bacterial load and 45 patients will have 14 days IV Meropenem.
Next they will all attend for their baseline visit. Here, they will be asked to provide a 24 hour sputum collected the day prior to the visit, a spontaneous sample collected within 4 hours from rising (sample used for sputum colour and microbiological analysis), undergo spirometry testing, incremental shuttle walk test, blood sampling (for inflammatory markers Erythrocyte Sedimentation Rate, C Reactive Protein, Full Blood Count, procalcitonin), fill out a leicester cough questionnaire to assess their cough (LCQ) and a health related quality of life questionnaire (St George's respiratory questionnaire, SGRQ).
All patients will be started on intravenous meropenem 2g, tds (assuming no previous documented resistant microbiology results or allergies).
They will all return on day 7 for a check on their clinical progress. At this time they will again provide a 24hour sputum, spontaneous sputum sample and blood samples as documented above. Arm one (intervention arm) will have their antibiotics stopped on day 8 if the bacterial load is less than 10^6cfu/ml. Arm two will continue intravenous meropenem regardless of bacterial count.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients aged 18 and above
- •An established primary diagnosis of non cystic fibrosis bronchiectasis
- •Patients need to meet the criteria for needing intravenous antibiotic therapy.
- •Only the first exacerbation per patient will be used.
排除标准
- •Patients with organisms resistant in vitro to Meropenem (this is known from previous sputum microbiology but is rare in our cohort);
- •Current smokers or ex-smokers of less than 1 year;
- •Cystic fibrosis;
- •Active allergic bronchopulmonary aspergillosis;
- •Active tuberculosis;
- •Poorly controlled asthma necessitating long term oral corticosteroids;
- •Pregnancy or breast feeding;
- •Active malignancy;
- •Severe chronic obstructive pulmonary disease (COPD) on long term oxygen therapy;
- •Patients requiring non invasive or invasive ventilation;
- •Known allergy to Meropenem which is very rare in our cohort.
研究组 & 干预措施
14 days Duration
14 days of antibiotics regardless of bacterial load.
干预措施: Colomycin (Drug)
Bacterial load guided duration
Antibiotics stopped early on day 8 or day 11 if the bacterial load when checked on day 7 and day 10 is less than 10^6cfu/ml.
干预措施: Duration (Other)
Bacterial load guided duration
Antibiotics stopped early on day 8 or day 11 if the bacterial load when checked on day 7 and day 10 is less than 10^6cfu/ml.
干预措施: Colomycin (Drug)
Bacterial load guided duration
Antibiotics stopped early on day 8 or day 11 if the bacterial load when checked on day 7 and day 10 is less than 10^6cfu/ml.
干预措施: Meropenem (Drug)
结局指标
主要结局
Time to next exacerbation
时间窗: up to 1 year following IV antibiotics
The time to next exacerbation (all the patients are followed up in the bronchiectasis clinic and record the date of their exacerbations where they receive antibiotic therapy).
Proportion of patients that stopped antibiotics early
时间窗: 14 days
The proportion of patients where we can stop antibiotic treatment early guided by bacterial load either on day 8 or day 11 instead of usual day 14 course. All patients will have a minimum of 7 days of intravenous antibiotics.
次要结局
- Clinical recovery at days 14 and 21(21 days)
- Antibiotic side effects(14 days)
- Correlation of bacterial load with clinical response(21 days)