US-based Theravance Biopharma has started patient enrolment in the Telavancin Observational Use Registry (TOUR), a large-scale study designed to evaluate how its FDA-approved bactericidal, once-daily, antibiotic, Vibativ (telavancin), is being used by healthcare practitioners to treat patients.
The company intends to create an expansive knowledge base to guide optimal clinical use and the drug’s future development, by collecting and examining real-world data related to VIBATIV treatment patterns, clinical effectiveness and safety outcomes in medical practise.
Vibativ is an injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
In several large, multinational registrational trials, the drug has shown efficacy against difficult-to-treat infections. The trials involved one of the largest groups of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections.
Theravance Biopharma Development and Operations senior vice-president Frank Pasqualone said: "We are undertaking this observational use study as an important component of our strategy to enhance our understanding of the clinical use of Vibativ.
"With the extensive data we collect on how Vibativ therapy is managed by healthcare practitioners in the clinic, we will be able to further educate the broader healthcare community about the drug’s optimal clinical use."
Around 1,000 patients from about 50 sites in the US will be enrolled in this multi-centre, observational TOUR study.
In this non-interventional study, all treatment decisions will be at the discretion of the patient’s healthcare provider prior to patient enrolment.
The company said that patients in the trial will have treatment started in both hospital-based settings and out-patient infusion sites.
Patients must have received at least one dose of Vibativ and meet specified inclusion criteria in order to qualify for enrolment in the trial.
Theravance chairman and chief executive officer Rick Winningham said: "Data from this study can support Vibativ as an essential tool in the antibiotic arsenal of physicians and healthcare practitioners."
In the US, Vibativ is approved to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.
The drug is also indicated to treat cSSSI caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.