Therapeutic serum concentration monitoring for nontuberculous mycobacteria patients

Therapeutic serum and pulmonary concentration monitoring of clofazimine - Therapeutic serum and pulmonary concentration monitoring of clofazimine

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041053

Enrollment

Registered

2020-07-10

Start date

2020-07-02

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Pulmonary nontuberculous mycobacteriosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with pulmonary nontuberculous mycobacteria who are admitted to Fukujuji hospital or outpatient treatment 2)Subjects who have the consent ability 3)Subjects who are taking clofazimine newly or who are already taking clofazimine when participating in the study

Exclusion criteria

Exclusion criteria: 1)Subjects who are pregnant or breastfeeding 2)Subjects whose treatment start date are unknown 3)Subjects who are judged as inadequate by physicians

Design outcomes

Primary

Measure	Time frame
Occurence of adverse effects, including pigmentation and QTc interval prolongation	—

Secondary

Measure	Time frame
Culture negative conversion rate, serum drug concentration, pulmonary drug concentration, drug intake time and blood sampling time, physical findings, clinical laboratory test data, medical histories, comorbidities, concomitant medications	—

Countries

Japan

Contacts

Public Contactkazuhiko hanada

Meiji Pharmaceutical University Department of Pharmacometrics and Pharmacokinetics

hanada@my-pharm.ac.jp0424958869

Outcome results