Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Pharmacokinetics

Study type: Observational

Funder types: Other

Identifiers

NCT02169141

LC-20

Details and patient eligibility

About

This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).

Full description

Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age> 18yrs
• culture positive
• diagnosis of MDR-TB

Exclusion criteria

• DM2
• Pregnancy
• allergy to IV canula material
• insertion of IV canula not possibele

Trial design

20 participants in 1 patient group

PK of Levofloxacin-Capreomycin

Description:

Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB

Treatment:

Other: Pharmacokinetics