Tuberculosis, Multidrug-Resistant
Conditions
Keywords
Centralized Therapeutic Drug Monitoring, Fluoroquinolones
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.
Interventions
PROCEDURECentralized 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.
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of centralized TDM | 1 week | Turn-around time between plasma sampling and receiving dosing advice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Australia, Belarus, Brazil, Greece, Italy, Latvia, Mexico, Netherlands, Portugal, South Africa, Sweden, Tanzania, United Kingdom
Contacts
Primary ContactJan-WIllem Alffenaar, PhD
Backup ContactSimone van den Elsen, BSc
Outcome results
None listed