PRISM-UDR
Research type
Research Study
Full title
A multicenter, open-label, sponsor-blinded, randomized, active-controlled, parallel group, pivotal study to evaluate the efficacy, safety, and tolerability of murepavadin given with ertapenem versus an anti-pseudomonal-β-lactam-based antibiotic in adult subjects with nosocomial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa
IRAS ID
254238
Contact name
Simon Tiberi
Contact email
Sponsor organisation
Polyphor Ltd.
Eudract number
2018-001159-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 20 days
Research summary
This research study will test a new antibiotic called murepavadin for patients who have developed pneumonia after being admitted to hospital (called hospital-acquired bacterial pneumonia [HABP]), or due to a lung infection that develops while a patient is being mechanically ventilated (called ventilator associated bacterial pneumonia [VABP]), which is thought to be or known to be caused by a bacteria called Pseudomonas aeruginosa (P. aeruginosa).
P. aeruginosa may cause infections that can be difficult to treat, as some P. aeruginosa have developed resistance against currently used antibiotics. Therefore, new effective treatments are needed. Murepavadin kills only P. aeruginosa bacteria and in a different way than other antibiotics.
The purpose of this study is to find out how effective and safe murepavadin is for the treatment of HABP or VABP thought to be or confirmed to be due to P. aeruginosa.
Patients participating in this study will receive either murepavadin given with ertapenem (another antibiotic that kills other types of bacteria besides P. aeruginosa that may also be causing the patient’s pneumonia) or either meropenem or piperacillin-tazobactam (both are approved antibiotics that are commonly used to treat HABP/VABP including those patients whose infection is caused by P. aeruginosa). Participation in the study may last up to 48 days. Participants will undergo several procedures to evaluate how the study drug is affecting their condition, including measurement of vital signs; muscle strength assessments (if awake); chest X-ray; ECGs; blood, urine and respiratory sample collection for laboratory tests; and neurological assessments.
About 250 patients will take part in this study at approximately 100 hospitals worldwide.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/2068
Date of REC Opinion
11 Dec 2018
REC opinion
Unfavourable Opinion