Nontuberculous Mycobacterial Diseases Clinical Trial
— NTMOfficial title:
Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.
Status | Completed |
Enrollment | 26 |
Est. completion date | May 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - currently treated for NTM infection or recently diagnosed with NTM infection starting treatment at University Centre for Chronic Diseases Dekkerswald (Groesbeek), Centre for Revalidation Beatrixoord (Haren), or other outpatient clinics in The Netherlands. - Diagnosis and treatment according to American Thoracic Society (ATS) criteria for NTM infections. Patients with pulmonary NTM infections (possible with extrapulmonary localizations as well) are eligible - Treated with at least rifampicin and ethambutol and optionally with isoniazid, clarithromycin or azithromycin on a daily basis - Age at least 18 years - Patient has been using drugs for at least two weeks when steady state concentrations of the used drugs are expected - Informed consent has been signed Exclusion Criteria: - 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 based on chemistry parameters (grade 1 according to an international adverse event grading system, see http:/ctep.cancer.gov) or symptomatic liver dysfunction (nausea and vomiting). - Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs. - Patients with HIV infection, since these may show deviating pharmacokinetics for the drugs used in NTM disease. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Centre Groningen | Groningen | |
Netherlands | Radboud University Medical Centre Nijmegen | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment | after at least 2 weeks of treatment | No | |
Secondary | Determinants of pharmacokinetic parameters | after at least 2 weeks of treatment | No | |
Secondary | Assessment of MIC values and pharmacodynamic parameters for response | once a month starting after two weeks of treatment;last assessment at 6 months | No | |
Secondary | Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity | entire study | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05294146 -
Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease
|
Phase 2 |