Clinical Trial: PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

Brief Summary: A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.

Detailed 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.


Sponsor: Radboud University

Current Primary Outcome: Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment [ Time Frame: after at least 2 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Determinants of pharmacokinetic parameters [ Time Frame: after at least 2 weeks of treatment ]
  • 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 ]
  • Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity [ Time Frame: entire study ]


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: January 18, 2010
Date Started: January 2010
Date Completion:
Last Updated: May 21, 2012
Last Verified: May 2012