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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

January 18, 2010
May 21, 2012
January 2010
March 2011   (final data collection date for primary outcome measure)
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment [ Time Frame: after at least 2 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01051752 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients
Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples for pharmacokinetic analysis will be retained. Sputum samples for pharmacodynamic analysis will be retained.

Probability Sample

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.

Nontuberculous Mycobacterial Diseases
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01051752
NL29420.091.09
No
Radboud University
Radboud University
Not Provided
Principal Investigator: Rob Aarnoutse, Pharm D PhD Radboud University
Principal Investigator: Jan- Willem Alffenaar, PharmD PhD University Medical Centre Groningen
Radboud University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP