POSY-TEICO OBS13842
Research type
Research Study
Full title
Prospective, observational cohort, evaluating the incidence of nephrotoxicity, and other adverse events of interest, in patients treated with the higher recommended teicoplanin loading dose (12mg/kg twice a day), and comparison with external historical comparator data
IRAS ID
211166
Contact name
Jane Minton
Contact email
Sponsor organisation
Sanofi
Duration of Study in the UK
2 years, 10 months, 28 days
Research summary
This is a multicentre, post authorisation observational study to estimate the nephrotoxicity potential (toxic effect on the kidneys) of the higher loading dose of teicoplanin (which is 12mg/kg twice a day), using real world clinical practice data.
This is an observational study with no experimental intervention utilized.Enrolled patients will receive treatment and evaluations for their infection as determined by their treating physicians in accordance with local standard of care.
For purposes of this study, Health Care Providers (HCPs) will be requested to record information on enrolled patients at the time of study enrolment up until 60 days post end of treatment with teicoplanin.
The full study duration is expected to be approximately 3 years including an approximate 19 month enrolment period.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0442
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion