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Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients

NCT03409315 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2019-10-10

No results posted yet for this study

Summary

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.

In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.

Conditions

  • Tuberculosis, Multidrug-Resistant

Interventions

PROCEDURE

Centralized Therapeutic Drug Monitoring

Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Jan-WIllem Alffenaar, PhD · UMCG

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-10
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • Australia
  • Belarus
  • Brazil
  • Greece
  • Italy
  • Latvia
  • Mexico
  • Netherlands
  • Portugal
  • South Africa
  • Sweden
  • Tanzania
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409315 on ClinicalTrials.gov