To describe the steady state pharmacokinetics of rifampicin, desacetylrifampicin, ethambutol, claritromycin, 14alpha-OH clarithromycine and azithromycin in plasma of adult patients with NTM infections in the Netherlands
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment
Secondary outcome
1. Determinants of pharmacokinetic parameters
2. Assessment of MIC values and pharmacodynamic parameters for response.
3. Association of pharmacokinetic and pharmacodynamic parameters with treatment
outcome and toxicity.
Background summary
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.
Study objective
To describe the steady state pharmacokinetics of rifampicin,
desacetylrifampicin, ethambutol, claritromycin, 14alpha-OH clarithromycine and
azithromycin in plasma of adult patients with NTM infections in the Netherlands
Study design
This is a prospective observational study in which pharmacokinetic and
pharmacodynamic parameters are evaluated in a cohort of patient with NTM
diseases.
Study burden and risks
Extra time investment for three extra outpatient controls and the day of
hospitalisation for the PK curve.
Installing a Venflon can cause pain and light bruising during introduction.
Keeping a medication diary will take a few minutes per day.
nijmeegsebaan 33
6561 KE Groesbeek
NL
nijmeegsebaan 33
6561 KE Groesbeek
NL
Listed location countries
Age
Inclusion criteria
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.
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
•Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs.
•Patients with HIV infection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29420.091.09 |