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Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

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ClinicalTrials.gov Identifier: NCT02169141
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Collaborators:
Republican Scientific and Practical Centre for Pulmonology and TB
National Institute for Public Health and the Environment (RIVM)
Information provided by (Responsible Party):
JWC Alffenaar, 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).

Condition or disease Intervention/treatment
Tuberculosis Other: Pharmacokinetics

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
PK of Levofloxacin-Capreomycin
Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB
Other: Pharmacokinetics
multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MDR-TB patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169141


Locations
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Belarus
Republican Scientific and Practical Center for TB and Pulmonology
Minsk, Belarus, 220053
Sponsors and Collaborators
University Medical Center Groningen
Republican Scientific and Practical Centre for Pulmonology and TB
National Institute for Public Health and the Environment (RIVM)
Investigators
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Principal Investigator: JW C Alffenaar, PhD PharmD UMCG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JWC Alffenaar, PhD PharmD Clinical Pharmacologist Associate Professor, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02169141    
Other Study ID Numbers: LC-20
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by JWC Alffenaar, University Medical Center Groningen:
pharmacokinetics
pharmacodynamics
MDR-TB
Levofloxacin
Capreomycin
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections