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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01051752
First received: January 18, 2010
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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


Condition
Nontuberculous Mycobacterial Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment [ Time Frame: after at least 2 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 26
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051752

Locations
Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Rob Aarnoutse, Pharm D PhD Radboud University
Principal Investigator: Jan- Willem Alffenaar, PharmD PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01051752     History of Changes
Other Study ID Numbers: NL29420.091.09
Study First Received: January 18, 2010
Last Updated: May 21, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Nontuberculous mycobacterial diseases
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014