Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

Completed

• Conditions: Tuberculosis
• Interventions: Other: Pharmacokinetics

• Registration Number: NCT02169141
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-11
• Status Verified: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC/MIC ratio of Levofloxacin	after day 8 of treatment	The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), \[AUC0-24h /MIC\], after administration of Levofloxacin.
Cmax/MIC ratio of Capreomycin	after day 8 of treatment	The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, \[Cmax/MIC\], after administration of Capreomycin.

Secondary Outcome Measures

Name	Time	Method
Volume of Distribution	after day 8 of treatment	Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated
Clearance	after day 8 of treatment	Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated

Trial Locations

Locations (1)

Republican Scientific and Practical Center for TB and Pulmonology; 🇧🇾 Minsk, Belarus