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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin, prospective | Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin. |
| |
| Levofloxacin, prospective | Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin |
| |
| Moxifloxacin, historical controls | Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin. | ||
| Levofloxacin, historical controls | Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centralized Therapeutic Drug Monitoring | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of centralized TDM | Turn-around time between plasma sampling and receiving dosing advice | 1 week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Sputum smear and culture positive MDR-TB patients treated with either moxifloxacin or levofloxacin in multiple clinical centres worldwide.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan-WIllem Alffenaar, PhD | Contact | +31503614071 | j.w.c.alffenaar@umcg.nl | |
| Simone van den Elsen, BSc | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jan-WIllem Alffenaar, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles and Caboolture Hospitals | Not yet recruiting | Brisbane | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32554740 | Derived | van den Elsen SH, Sturkenboom MG, Akkerman O, Barkane L, Bruchfeld J, Eather G, Heysell SK, Hurevich H, Kuksa L, Kunst H, Kuhlin J, Manika K, Moschos C, Mpagama SG, Munoz Torrico M, Skrahina A, Sotgiu G, Tadolini M, Tiberi S, Volpato F, van der Werf TS, Wilson MR, Zuniga J, Touw DJ, Migliori GB, Alffenaar JW. Prospective evaluation of improving fluoroquinolone exposure using centralised therapeutic drug monitoring (TDM) in patients with tuberculosis (PERFECT): a study protocol of a prospective multicentre cohort study. BMJ Open. 2020 Jun 16;10(6):e035350. doi: 10.1136/bmjopen-2019-035350. |
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| Republican Scientific and Practical Centre of Pulmonology and Tuberculosis | Not yet recruiting | Minsk | Belarus |
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| Hélio Fraga Reference Center | Not yet recruiting | Rio de Janeiro | Brazil |
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| Athens Chest Hospital "Sotiria" | Recruiting | Athens | Greece |
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| Alma Mater Studiorum University of Bologna | Not yet recruiting | Bologna | Italy |
|
| Reuh Tldc | Not yet recruiting | Upeslejas | Latvia |
|
| Instituto Nacional de Enfermedades Respiratorias | Not yet recruiting | Mexico City | Mexico |
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| University Medical Center Groningen Beatrixoord | Not yet recruiting | Haren | Netherlands |
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| Vila Nova Gaia/Espinho Medical School | Not yet recruiting | Vila Nova de Gaia | Portugal |
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| University of Cape Town, Lung Insitute | Not yet recruiting | Cape Town | South Africa |
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| Karolinska University Hospital | Not yet recruiting | Stockholm | Sweden |
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| Kibong'oto Infectious Diseases Hospital | Not yet recruiting | Sanya Juu | Tanzania |
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| Royal London Hospital | Not yet recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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