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NCT03409315 Clinical Trial

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

Tuberculosis, Multidrug-Resistant Clinical Trial

— PERFECT  

Official title:
Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03409315
Other study ID # CTDM/FQ1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 10, 2018
Est. completion date December 2020

Study information
Verified date October 2019
Source University Medical Center Groningen
Contact Jan-WIllem Alffenaar, PhD
Phone +31503614071
Email j.w.c.alffenaar@umcg.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 360
Est. completion date December 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Criteria:

- Pregnancy or breast feeding

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Australia The Prince Charles and Caboolture Hospitals Brisbane
Belarus Republican Scientific and Practical Centre of Pulmonology and Tuberculosis Minsk
Brazil Hélio Fraga Reference Center Rio De Janeiro
Greece Athens Chest Hospital "Sotiria" Athens
Italy Alma Mater Studiorum University of Bologna Bologna
Latvia Reuh Tldc Upeslejas
Mexico Instituto Nacional de Enfermedades Respiratorias Mexico City
Netherlands University Medical Center Groningen Beatrixoord Haren
Portugal Vila Nova Gaia/Espinho Medical School Vila Nova De Gaia
South Africa University of Cape Town, Lung Insitute Cape Town
Sweden Karolinska University Hospital Stockholm
Tanzania Kibong'oto Infectious Diseases Hospital Sanya Juu
United Kingdom Royal London Hospital London

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of centralized TDM Turn-around time between plasma sampling and receiving dosing advice 1 week
Secondary Impact of centralized TDM Comparison of % patients with converted sputum smear and culture between prospective patients with TDM and matched historical controls without TDM (1:2) 2 months
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