Pharmacokinetic study of minocycline in patients with nontuberculous mycobacterial disease

Pharmacokinetic study of minocycline in patients with nontuberculous mycobacterial disease - MINO-PK

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54666

Enrollment

Registered

2021-04-07

Start date

2023-06-23

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

infection caused by a nontuberculous mycobacteria NTM disease

Interventions

Patients will receive two 5-day dosing periods of 200 mg minocycline

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - ATS/ERS/IDSA diagnostic criteria for NTM disease are met. - The subject is eligible to start the guideline-recommended rifampicin-based regimen according to the treating physician. .- Age >= 18 years. - Signed and dated patient informed consent

Exclusion criteria

Exclusion criteria: - ATS/ERS/IDSA diagnostic criteria for NTM disease are met. - The subject is eligible to start the guideline-recommended rifampicin-based regimen according to the treating physician. - Age >= 18 years. - Signed and dated patient informed consent

Design outcomes

Primary

Measure	Time frame
Total exposure (area under the concentration versus time curve from T=0 up to 24 hours, after a 5-day dosing periode of minocycline; AUC0-24h), pre-dose concentration (Ctrough) and peak serum concentration (Cmax) of minocycline before and after start of a rifampicin containing regimen	—

Secondary

Measure	Time frame
Pharmacokinetic parameters of rifampicin.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)