Pharmacokinetics and pharmacodynamics of drugs for Nontuberculous Mycobacterial diseases in Dutch patients
- Conditions
- non tuberculous mycobacteria10028440
- Registration Number
- NL-OMON32679
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
Patients:
•Currently treated for NTM infection or recently diagnosed with NTM infection starting treatment at ULC Dekkerswald, Groesbeek, or Centre for Revalidation Beatrixoord, Haren, the Netherlands.
•Diagnosis and treatment according to ATS criteria for NTM infections. Patients with pulmonary (eventually with extrapulmonary localizations) NTM infections are eligible.
•Treated with at least rifampicin and ethambutol and optionally with claritromycin or azitromycin on a daily basis.
•Age >=18 years.
•Patient has been using drugs for at least two weeks when steady state concentrations of rifampicin and azithromycin is expected.
•Informed consent has been signed.
•The medical state of the patients does not allow inclusion according to the physician in attendance.
•The patients* clinical parameters urge immediate cessation of drugs.
•The patient is pregnant.
•Significant hepatic or renal dysfunction
•Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs.
•Patients with HIV infection
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Determinants of pharmacokinetic parameters<br /><br>2. Assessment of MIC values and pharmacodynamic parameters for response.<br /><br>3. Association of pharmacokinetic and pharmacodynamic parameters with treatment<br /><br>outcome and toxicity.</p><br>