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Infectious Diseases clinical trial

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 (POSY-TEICO)

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.

Inclusion criteria:
• Adult patients (aged 18 years or older), with infection types for which the higher loading dose of teicoplanin is
approved (as per SmPC), who are prescribed teicoplanin loading doses of 12 mg/kg twice a day by the treating
physician
• Agree to participate and sign the ICF (signed by the patient or by the patient’s representative)

Exclusion criteria:
• Age less than 18 years on the date of inclusion
• Patients with a history of hypersensitivity to teicoplanin (or to any of the excipients listed in SmPC or to vancomycin).

Principal Investigator for this trial: Mr Tim Hills

Research Ethics Committee Reference: 16/YH/0442

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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