An observational study in Tuberculosis, Multidrug-Resistant, sponsored by University Medical Center Groningen. Status unknown at 13 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by University Medical Center Groningen · Observational
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.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's planned enrollment of 360 is below the median of 410 across 42 observational studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sputum smear and culture positive MDR-TB patients treated with either moxifloxacin or levofloxacin in multiple clinical centres worldwide.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin.
Procedure: Centralized Therapeutic Drug Monitoring
Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin
Procedure: Centralized Therapeutic Drug Monitoring
Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin.
Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin.
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.
Feasibility of centralized TDM
Turn-around time between plasma sampling and receiving dosing advice
Time frame: 1 week
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)
Time frame: 2 months
Started Feb 2018 (actual). Primary completion is estimated for Nov 2020, 33 months after the start.
Of 19 observational studies under Tuberculosis, Multidrug-Resistant, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 90. This study's planned 33 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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