PDF(Pubmed)
Abstract：
BACKGROUND: The effect of dual systemic antibiotic therapy against Pseudomonas aeruginosa in patients with pre-existing lung disease is unknown. To assess whether dual systemic antibiotics against P. aeruginosa in outpatients with COPD, non-cystic fibrosis (non-CF) bronchiectasis, or asthma can improve outcomes.
METHODS: Multicenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365.
RESULTS: The trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037.
CONCLUSIONS: Use of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial.
BACKGROUND: ClinicalTrials.gov, NCT03262142, registration date 2017-08-25.
METHODS: Multicenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365.
RESULTS: The trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037.
CONCLUSIONS: Use of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial.
BACKGROUND: ClinicalTrials.gov, NCT03262142, registration date 2017-08-25.
摘要：
背景：在已有肺部疾病的患者中，针对铜绿假单胞菌的双重全身性抗生素治疗的效果尚不清楚。评估门诊COPD患者对铜绿假单胞菌的双重全身性抗生素，非囊性纤维化（非CF）支气管扩张，或者哮喘可以改善结果。
方法：多中心，随机化，在丹麦7家呼吸门诊进行的开放标签试验.COPD门诊患者，非CF支气管扩张，或当前铜绿假单胞菌阳性下呼吸道培养的哮喘（根据急性发作症状获得的临床常规样本，无需住院治疗），不管以前的铜绿假单胞菌状态，目前不需要住院治疗，在过去一年内，至少有两次中度或一次需要住院治疗的恶化符合资格。患者被分配1：1至14天的双重全身性抗假单克隆抗生素或无抗生素治疗。主要结果是泼尼松龙或需要抗生素的恶化或死亡时间，从第20天到第365天。
结果：由于在COVID-19大流行期间缺乏招募，该试验过早停止，这一决定得到了数据和安全监察委员会的认可.49名门诊患者被纳入研究。与对照组相比，抗生素组的主要结局风险降低（HR0.51（95CI0.27-0.96），p=0.037)。在双重抗生素组中，一年内恶化的入院发生率为1.1（95CI0.6-1.7）。对照组2.9（95CI1.3-4.5），p=0.037。
结论：在门诊慢性肺部疾病患者中，对铜绿假单胞菌使用双系统抗生素14天，没有必要住院治疗，显著改善临床结果。主要限制是试验过早结束。
背景：ClinicalTrials.gov，NCT03262142，注册日期2017-08-25。
方法：多中心，随机化，在丹麦7家呼吸门诊进行的开放标签试验.COPD门诊患者，非CF支气管扩张，或当前铜绿假单胞菌阳性下呼吸道培养的哮喘（根据急性发作症状获得的临床常规样本，无需住院治疗），不管以前的铜绿假单胞菌状态，目前不需要住院治疗，在过去一年内，至少有两次中度或一次需要住院治疗的恶化符合资格。患者被分配1：1至14天的双重全身性抗假单克隆抗生素或无抗生素治疗。主要结果是泼尼松龙或需要抗生素的恶化或死亡时间，从第20天到第365天。
结果：由于在COVID-19大流行期间缺乏招募，该试验过早停止，这一决定得到了数据和安全监察委员会的认可.49名门诊患者被纳入研究。与对照组相比，抗生素组的主要结局风险降低（HR0.51（95CI0.27-0.96），p=0.037)。在双重抗生素组中，一年内恶化的入院发生率为1.1（95CI0.6-1.7）。对照组2.9（95CI1.3-4.5），p=0.037。
结论：在门诊慢性肺部疾病患者中，对铜绿假单胞菌使用双系统抗生素14天，没有必要住院治疗，显著改善临床结果。主要限制是试验过早结束。
背景：ClinicalTrials.gov，NCT03262142，注册日期2017-08-25。
