PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients (NTM)
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.
Nontuberculous Mycobacterial Diseases
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients|
- Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment [ Time Frame: after at least 2 weeks of treatment ] [ Designated as safety issue: No ]
- Determinants of pharmacokinetic parameters [ Time Frame: after at least 2 weeks of treatment ] [ Designated as safety issue: No ]
- Assessment of MIC values and pharmacodynamic parameters for response [ Time Frame: once a month starting after two weeks of treatment;last assessment at 6 months ] [ Designated as safety issue: No ]
- Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Blood samples for pharmacokinetic analysis will be retained. Sputum samples for pharmacodynamic analysis will be retained.
|Study Start Date:||January 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Patients with NTM infection are generally middle aged or higher aged, white males with COPD or bronchiectasis. They will be recruited from the outpatient clinics of University Centre for Chronic Diseases Dekkerswald, Tuberculosis Centre Beatrixoord or other outpatient clinics in The Netherlands. Both newly diagnosed and already treated patients with NTM disease will be recruited.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051752
|Radboud University Medical Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands|
|University Medical Centre Groningen|
|Principal Investigator:||Rob Aarnoutse, Pharm D PhD||Radboud University|
|Principal Investigator:||Jan- Willem Alffenaar, PharmD PhD||University Medical Center Groningen|