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

NCT ID: NCT01051752

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Nontuberculous Mycobacterial Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NTM infection

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rob Aarnoutse, Pharm D PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Jan- Willem Alffenaar, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

Radboud University Medical Centre Nijmegen

Nijmegen, Gelderland, Netherlands

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

NL29420.091.09

Identifier Type: -

Identifier Source: org_study_id