Tuberculosis, Multidrug-Resistant Clinical Trial
— PERFECTOfficial title:
Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
NCT number | NCT03409315 |
Other study ID # | CTDM/FQ1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 10, 2018 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | December 2020 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | The Prince Charles and Caboolture Hospitals | Brisbane | |
Belarus | Republican Scientific and Practical Centre of Pulmonology and Tuberculosis | Minsk | |
Brazil | Hélio Fraga Reference Center | Rio De Janeiro | |
Greece | Athens Chest Hospital "Sotiria" | Athens | |
Italy | Alma Mater Studiorum University of Bologna | Bologna | |
Latvia | Reuh Tldc | Upeslejas | |
Mexico | Instituto Nacional de Enfermedades Respiratorias | Mexico City | |
Netherlands | University Medical Center Groningen Beatrixoord | Haren | |
Portugal | Vila Nova Gaia/Espinho Medical School | Vila Nova De Gaia | |
South Africa | University of Cape Town, Lung Insitute | Cape Town | |
Sweden | Karolinska University Hospital | Stockholm | |
Tanzania | Kibong'oto Infectious Diseases Hospital | Sanya Juu | |
United Kingdom | Royal London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Australia, Belarus, Brazil, Greece, Italy, Latvia, Mexico, Netherlands, Portugal, South Africa, Sweden, Tanzania, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of centralized TDM | Turn-around time between plasma sampling and receiving dosing advice | 1 week | |
Secondary | 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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