Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

Tuberculosis Clinical Trial

Official title:

Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169141
• Other study ID #: LC-20
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: June 20, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2014
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belarus: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Other:
• Pharmacokinetics
multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters

Locations

Country	Name	City	State
Belarus	Republican Scientific and Practical Center for TB and Pulmonology	Minsk

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	National Institute for Public Health and the Environment (RIVM), Republican Scientific and Practical Centre for Pulmonology and TB

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PK-model	A population PK model will be developed using an iterative 2-stage Bayesian procedure.	after day 8 of treatment	No
Other	Limited sampling strategy	Limited sampling strategies were investigated subsequently using a Bayesian analysis. The best possible strategies for will be evaluated by a Bland-Altman analysis for correlation of predicted and observed AUC0-24.	after day 8 of treatment	No
Primary	AUC/MIC ratio of Levofloxacin	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.	after day 8 of treatment	No
Primary	Cmax/MIC ratio of Capreomycin	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.	after day 8 of treatment	No
Secondary	Volume of Distribution	Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated	after day 8 of treatment	No
Secondary	Clearance	Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated	after day 8 of treatment	No