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

• Conditions: Tuberculosis, Multidrug-Resistant
• Interventions: Procedure: Centralized Therapeutic Drug Monitoring

• Registration Number: NCT03409315
• Lead Sponsor: University Medical Center Groningen

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-02-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moxifloxacin, prospective	Centralized Therapeutic Drug Monitoring	Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin.
Levofloxacin, prospective	Centralized Therapeutic Drug Monitoring	Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin

Primary Outcome Measures

Name	Time	Method
Feasibility of centralized TDM	1 week	Turn-around time between plasma sampling and receiving dosing advice

Secondary Outcome Measures

Name	Time	Method
Impact of centralized TDM	2 months	Comparison of % patients with converted sputum smear and culture between prospective patients with TDM and matched historical controls without TDM (1:2)

Trial Locations

Locations (13)

Athens Chest Hospital "Sotiria"; 🇬🇷 Athens, Greece

Vila Nova Gaia/Espinho Medical School; 🇵🇹 Vila Nova De Gaia, Portugal

Kibong'oto Infectious Diseases Hospital; 🇹🇿 Sanya Juu, Tanzania

Reuh Tldc; 🇱🇻 Upeslejas, Latvia

University Medical Center Groningen Beatrixoord; 🇳🇱 Haren, Netherlands

Instituto Nacional de Enfermedades Respiratorias; 🇲🇽 Mexico City, Mexico

The Prince Charles and Caboolture Hospitals; 🇦🇺 Brisbane, Australia

Republican Scientific and Practical Centre of Pulmonology and Tuberculosis; 🇧🇾 Minsk, Belarus

Alma Mater Studiorum University of Bologna; 🇮🇹 Bologna, Italy

Hélio Fraga Reference Center; 🇧🇷 Rio De Janeiro, Brazil

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

University of Cape Town, Lung Insitute; 🇿🇦 Cape Town, South Africa

Royal London Hospital; 🇬🇧 London, United Kingdom