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NCT Number: NCT02169141

Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis, Multidrug-Resistant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Republican Scientific and Practical Center for TB and Pulmonology

Minsk, 220053, Belarus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacokinetics

Other

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

Primary outcomes

  1. AUC/MIC ratio of Levofloxacin

    Time frame: 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.

  2. Cmax/MIC ratio of Capreomycin

    Time frame: 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 outcomes

  1. Volume of Distribution

    Time frame: 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

  2. Clearance

    Time frame: 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

Other outcomes

  1. PK-model

    Time frame: after day 8 of treatment

    A population PK model will be developed using an iterative 2-stage Bayesian procedure.

  2. Limited sampling strategy

    Time frame: after day 8 of treatment

    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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • National Institute for Public Health and the Environment (RIVM)
  • Republican Scientific and Practical Centre for Pulmonology and TB

Registry information

Official study title

Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2014
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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