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

Nontuberculous Mycobacterial Diseases Clinical Trial

— NTM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051752
• Other study ID #: NL29420.091.09
• Status: Completed
• Phase: N/A
• First received: January 18, 2010
• Last updated: May 21, 2012
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mycobacterium Infections
• Nontuberculous Mycobacterial Diseases

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	Radboud University Medical Centre Nijmegen	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

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