EUCTR2018-001590-24-GB进行中（未招募）1 期
A Trial of the Safety, Tolerability and Efficacy of 2 doses of Cayston (Aztreonam Lysine) compared to placebo in participants with bronchiectasis. - VITAL-BE Value of inhaled treatment with Aztreonam in bronchiectasis
niversity of Dundee0 个研究点目标入组 100 人开始时间: 2019年1月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •= 18 years of age
- •Able to give informed consent
- •Clinical diagnosis of Bronchiectasis
- •CT scan of the chest demonstrating bronchiectasis in 1 or more lobes
- •A history of at least 3 exacerbations in the previous 12 months
- •Bronchiectasis severity index score >4
- •Pseudomonas aeruginosa or other Gram-negative respiratory pathogen detected in sputum or bronchoalveolar lavage on at least 1 occasion in the previous 12 months.
- •A sputum sample that is culture positive for P. aeruginosa or other Gram-negative respiratory pathogens sent at the screening visit and within 35 days of randomization. Pre-specified eligible organisms include Eschericia coli, Haemophilus influenzae, Moraxella catarrhalis, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens, Achromobacter, Enterobacter and Stenotrophomonas maltophilia
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Participant has cystic fibrosis
- •Immunodeficiency requiring replacement immunoglobulin.
- •Active tuberculosis or nontuberculous mycobacterial infection (defined as currently under treatment, or requiring treatment in the opinion of the investigator).
- •Recent significant haemoptysis (a volume requiring clinical intervention, within the previous 4 weeks).
- •Treatment with inhaled, systemic or nebulized anti-Pseudomonal antibiotics in the 28 days prior to randomization
- •Oral macrolides which have been taken for a period of less than 3 months prior to the start of the trial.
- •Treatment of an exacerbation and receiving antibiotic treatment within 4 weeks of randomization
- •Primary diagnosis of COPD associated with >20 pack years smoking history.
- •History of poorly controlled asthma or a history of bronchospasm with inhaled antibiotics.
- •Pregnant or lactating females.
- •Participants with FEV1 <30% predicted value at screening.
- •Previous history of intolerance to Aztreonam or bronchospasm reported with any other inhaled anti-bacterial.
- •Glomerular filtration rate (eGFR) below 30ml/min/1.73m2 or requiring dialysis. This will be determined at screening.
- •Use of any investigational drugs within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer.
- •Unstable co-morbidities (cardiovascular disease, active malignancy) which in the opinion of the investigator would make participation in the trial not in the participants best interest.
- •Long term oxygen therapy
- •Women of child bearing age or male partners of women of child bearing age and not practicing a method of acceptable birth control (see below)
研究者
相似试验
进行中（未招募）
不适用
Study in healthy subjects and type 2 diabetic subjects to assess the safety, tolerability and pharmacokinetics of 28 days EV-077-3201-2TBS treatment, and the effects of thromboxane receptor antagonism on platelet function, vascular inflammation and vascular oxidative stressHealthy subjects and subjects with Type 2 DiabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-003808-20-DEEvolva SA96
尚未招募
不适用
PROSPECTIVE, TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF THE INTERSCOPE ENDOROTOR® RESECTION SYSTEM FOR DIRECT ENDOSCOPIC NECROSECTOMY OF WALLED OFF PANCREATIC NECROSISencapsulated pancreatic necrosiswalled-off pancreatic necrosis10017998NL-OMON47969Interscope Medical, Inc.5
进行中（未招募）
1 期
Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patientsTuberculosisCTIS2023-509885-39-00Stichting Radboud University Medical Center130
进行中（未招募）
1 期
High dose rifampicin for tuberculosis, PORTMedDRA version: 20.0Level: PTClassification code 10037440Term: Pulmonary tuberculosisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 25.1Level: LLTClassification code 10087871Term: Drug-sensitive pulmonary tuberculosisSystem Organ Class: 10021881 - Infections and infestationsTuberculosisEUCTR2022-000632-27-DKRadboud University Medical Center164
尚未招募
3 期
Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patientstuberculosis10028440NL-OMON53704Radboud Universitair Medisch Centrum25