Status:

UNKNOWN

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

Lead Sponsor:

University Medical Center Groningen

Conditions:

Tuberculosis, Multidrug-Resistant

Eligibility:

All Genders

18+ years

Brief 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 an...

Eligibility Criteria

Inclusion

  • Pulmonary MDR-TB
  • Sputum smear and sputum culture positive at baseline
  • Oral administration of either moxifloxacin or levofloxacin
  • Written informed consent (for use of the medical data)

Exclusion

  • Pregnancy or breast feeding

Key Trial Info

Start Date :

February 10 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2020

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT03409315

Start Date

February 10 2018

End Date

December 1 2020

Last Update

October 10 2019

Active Locations (13)

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Page 1 of 4 (13 locations)

1

The Prince Charles and Caboolture Hospitals

Brisbane, Australia

2

Republican Scientific and Practical Centre of Pulmonology and Tuberculosis

Minsk, Belarus

3

Hélio Fraga Reference Center

Rio de Janeiro, Brazil

4

Athens Chest Hospital "Sotiria"

Athens, Greece