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

Completed

• Conditions: Nontuberculous Mycobacterial Diseases

• Registration Number: NCT01051752
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment	after at least 2 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands

Radboud University Medical Centre Nijmegen; 🇳🇱 Nijmegen, Gelderland, Netherlands