Nontuberculous Mycobacterial Diseases
Conditions
Keywords
Nontuberculous mycobacterial diseases, pharmacokinetics, pharmacodynamics
Brief summary
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.
Detailed description
NTM are widely distributed in the environment and can especially be found in soil and water sources. These bacteria a very similar to tuberculosis bacteria. We are not that long aware that these bacteria can cause illness. Especially in patients with a chronic lung disease are sensitive to these bacteria and are susceptible to develop an infection. A lot of ambiguity consists about the best treatment of these infections. Up till now mainly the normal treatment for tuberculosis is used, however, the time period during which these medicines should be used and what dose should be used is mainly unknown. To investigate whether the dose used at this moment is right a pharmacokinetic curve will be taken at steady-state.
Interventions
None listed
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment | after at least 2 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Determinants of pharmacokinetic parameters | after at least 2 weeks of treatment |
| Assessment of MIC values and pharmacodynamic parameters for response | once a month starting after two weeks of treatment;last assessment at 6 months |
| Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity | entire study |
Countries
Netherlands
Outcome results
None listed