Trials / Unknown
UnknownNCT03409315
Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients
Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 360 (estimated)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-02-10
- Primary completion
- 2020-11-01
- Completion
- 2020-12-01
- First posted
- 2018-01-24
- Last updated
- 2019-10-10
Locations
13 sites across 13 countries: Australia, Belarus, Brazil, Greece, Italy, Latvia, Mexico, Netherlands, Portugal, South Africa, Sweden, Tanzania, United Kingdom
Source: ClinicalTrials.gov record NCT03409315. Inclusion in this directory is not an endorsement.