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Pharmacokinetics and pharmacodynamics of drugs for Nontuberculous Mycobacterial diseases in Dutch patients

Pharmacokinetics and pharmacodynamics of drugs for Nontuberculous Mycobacterial diseases in Dutch patients - PK and PD of drugs for Nontuberculous Mycobacterial diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32679
Enrollment
26
Registered
2009-12-14
Start date
2010-01-05
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non tuberculous mycobacteria

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: •Currently treated for NTM infection or recently diagnosed with NTM infection starting treatment at ULC Dekkerswald, Groesbeek, or Centre for Revalidation Beatrixoord, Haren, the Netherlands. •Diagnosis and treatment according to ATS criteria for NTM infections. Patients with pulmonary (eventually with extrapulmonary localizations) NTM infections are eligible. •Treated with at least rifampicin and ethambutol and optionally with claritromycin or azitromycin on a daily basis. •Age >=18 years. •Patient has been using drugs for at least two weeks when steady state concentrations of rifampicin and azithromycin is expected. •Informed consent has been signed.

Exclusion criteria

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 •Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs. •Patients with HIV infection

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment

Secondary

MeasureTime frame
1. Determinants of pharmacokinetic parameters 2. Assessment of MIC values and pharmacodynamic parameters for response. 3. Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)