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

Completed

• Conditions: Cystic fibrosis en CF; 10083624; 10004018; 10024970

• Registration Number: NL-OMON40371
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion 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;
* Ability to breathe through a mouthpiece and to use the inhaler;
* Ability to perform lung function tests;
* Written informed consent.

Exclusion Criteria

* Severe acute exacerbation of pulmonary infection (needing intravenous treatment);
* Patients receiving intravenous tobramycin treatment;
* Patients who are pregnant, planning to become pregnant or breastfeeding;
* 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: systemic bioavailability of inhaled tobramycin, defined as<br /><br>serum tobramycin AUC0-24hr.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include: serum tobramycin peak and trough levels, time to<br /><br>maximum serum level, adverse events. </p><br>