Rempex 506
Research type
Research Study
Full title
A PHASE 3, MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY OF CARBAVANCE (MEROPENEM/RPX7009) VERSUS BEST AVAILABLE THERAPY IN SUBJECTS WITH SELECTED SERIOUS INFECTIONS DUE TO CARBAPENEM RESISTANT ENTEROBACTERIACEAE
IRAS ID
163780
Contact name
Timothy Felton
Contact email
Sponsor organisation
Rempex Pharmaceuticals, Inc.
Eudract number
2014-000546-30
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
# 120040, US IND
Duration of Study in the UK
1 years, 2 months, 10 days
Research summary
Beta-lactam antimicrobials (e.g. Meropenem) are considered to be among the most useful classes of drugs for treatment of serious bacterial infections. However, there is an increasing problem of antibiotic resistant infections, such as complicated urinary tract infection (cUTI) acute pyelonephritis (AP), hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and bacteremia (bacteria in the blood), caused by a bacteria called carbapenem resistant Enterobacteriaceae (CRE).
Infections caused by CRE (the most common disease causing bacteria in a hospital setting) are associated with high death rates and have limited treatment options. A number of anti-infective drugs e.g. aminoglycosides, polymyxin B, colistin, tigecycline, or combinations of these have become the Best Available Therapy for these infections despite significant toxicities being associated with them.
The study drug, Carbavance, is a combination of two drugs, meropenem and the drug RPX7009, which is experimental and has not been approved in the UK. Meropenem (an approved antibiotic) for the treatment of certain types of bacterial infections, including cUTIs in the European Union and other bacterial infections in countries around the world. RPX7009 was developed to make meropenem more effective in patients with CRE infections. The combination drug (Carbavance) is being developed to treat antibiotic-resistant types of bacterial infections.
Patients will be randomly assigned by chance (picking straws) to one of two study treatments: Carbavance (2 grams meropenem; 2 grams RPX7009) or Best Available Antibacterial Therapy.
This study will test if Carbavance, is safe and effective when compared to antibacterial medications that are commonly used for the treatment of serious infections, suspected or known to be due to CRE, e.g., cUTI or AP, HABP, VABP, and/or bacteraemia.Rempex is Sponsoring this study, approximately 150 participants are expected to take part in this study at approximately 50 study Centres worldwide.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0255
Date of REC Opinion
21 Apr 2015
REC opinion
Favourable Opinion