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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Age >= 12 years
•Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
•Chronic Pseudomonas aeruginosa colonization requiring maintenance therapy with inhaled tobramycin, defined according to the Leeds criteria (>50% Pseudomonas aeruginosa positive airway cultures over last 12 months);
•Small airways obstruction present on spirometry (defined as follows: dissociation between FVC and FEF75 values (i.e. FEF75 at least 20% (absolute percent predicted) less than FVC);
•Ability to breathe through a mouthpiece and to use the inhaler;
•Ability to perform lung function tests;
•Written informed consent (12-18 years: child and parents; >= 18 years: patient).

•Severe acute exacerbation of pulmonary infection (needing intravenous treatment) within one month prior to start or during the study;
•Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
•Known aminoglycoside hypersensitivity;
•Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000 Hz);
•Start of nephrotoxic or ototoxic drugs, e.g. aminoglycosides, within 1 month prior to start or during the study;
•Use of systemic steroids (at a dose >= equivalent of 10 mg/day of prednisone) in the previous 2 weeks;
•Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator;
•Pregnancy or breast feeding;
•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.
•Use of Tobramycin Inhalation Powder as part of the maintenance therapy;• 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.
•Use of Tobramycin Inhalation Powder as part of the maintenance therapy

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