Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF

Haga Hospital0 个研究点开始时间: 2013年12月11日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Age = 18 years;
•FEV1 predicted = 30%;
•Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
•Chronic PA colonization requiring maintenance therapy with inhaled tobramycin;
•Ability to breathe through a mouthpiece and to use the inhaler;
•Ability to perform lung function tests;
•Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Severe acute exacerbation of pulmonary infection (needing intravenous treatment);
•Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
•Known aminoglycoside hypersensitivity;
•Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator;
•Participation in another drug-investigating clinical study at the start or within 1 month prior to the start;
•Inability to follow instructions of the investigator.

发起方

Haga Hospital