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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tuberculosis, Multidrug-Resistant

Intervention / Treatment
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* Procedure: Centralized Therapeutic Drug Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moxifloxacin, prospective<br>Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin. | Procedure: Centralized Therapeutic Drug Monitoring<br>* 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.<br>|
| Levofloxacin, prospective<br>Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin | Procedure: Centralized Therapeutic Drug Monitoring<br>* 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.<br>|
| Moxifloxacin, historical controls<br>Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin. | |
| Levofloxacin, historical controls<br>Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of centralized TDM | Turn-around time between plasma sampling and receiving dosing advice | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Centralized Therapeutic Drug Monitoring, Fluoroquinolones