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

NCT01051752 | Completed

• 1 other identifier: NL29420.091.09
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nontuberculous Mycobacterial Diseases

Keywords

Nontuberculous mycobacterial diseases; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment

  after at least 2 weeks of treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Radboud University Medical Centre Nijmegen

Nijmegen, Gelderland, Netherlands

Location

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Study Officials

• Rob Aarnoutse, Pharm D PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Jan- Willem Alffenaar, PharmD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

NL (2)