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

Last updated: October 8, 2019
Sponsor: University Medical Center Groningen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT03409315
CTDM/FQ1
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy or breast feeding

Study Design

Total Participants: 360
Study Start date:
February 10, 2018
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • The Prince Charles and Caboolture Hospitals

    Brisbane,
    Australia

    Site Not Available

  • Republican Scientific and Practical Centre of Pulmonology and Tuberculosis

    Minsk,
    Belarus

    Site Not Available

  • Hélio Fraga Reference Center

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Athens Chest Hospital "Sotiria"

    Athens,
    Greece

    Active - Recruiting

  • Alma Mater Studiorum University of Bologna

    Bologna,
    Italy

    Site Not Available

  • Reuh Tldc

    Upeslejas,
    Latvia

    Site Not Available

  • Instituto Nacional de Enfermedades Respiratorias

    Mexico City,
    Mexico

    Site Not Available

  • University Medical Center Groningen Beatrixoord

    Haren,
    Netherlands

    Site Not Available

  • Vila Nova Gaia/Espinho Medical School

    Vila Nova De Gaia,
    Portugal

    Site Not Available

  • University of Cape Town, Lung Insitute

    Cape Town,
    South Africa

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Kibong'oto Infectious Diseases Hospital

    Sanya Juu,
    Tanzania

    Site Not Available

  • Royal London Hospital

    London,
    United Kingdom

    Site Not Available

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