Nacubactam and Meropenen in patients with a complicated UTI.
Research type
Research Study
Full title
A NON-RANDOMIZED, OPEN-LABEL, ONE TREATMENT, ONE GROUP STUDY TO INVESTIGATE THE PHARMACOKINETICS OF RO7079901 AND MEROPENEM IN PATIENTS WITH A COMPLICATED URINARY TRACT INFECTION.
IRAS ID
232544
Contact name
Libuse Ratcliffe
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2016-004478-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, months, 23 days
Research summary
The group of antibiotics known as β-Lactams, a mainstay in the treatment of serious infections, have been compromised by the rapid emergence of a family of germs (carbapenem-resistant Enterobacteriaceae (CRE)) that are difficult to treat because they have high levels of resistance to antibiotics. CRE have become resistant to nearly all of the antibiotics available today and the Centres for Disease Control and Prevention (CDC) has classified these bacteria as ″an immediate public health threat that requires urgent and aggressive action″.
Based on preliminary Centres for Disease Control and Prevention pilot surveillance system, many CRE infections involve the urinary tract. If ineffectively treated, complicated urinary tract infection (cUTI) can result in bloodstream infections. Considering that the mortality rate in patients with CRE blood stream infections is nearly at 50%, it is critical to find novel treatments for this patient population.
The main purpose of this study is to evaluate how the body processes the combination of a new drug Nacubactam (RO7079901)and an antibiotic called Meropenem. It will also study the safety and tolerability of the treatments, the change in any symptoms participant may be experiencing, and the effect on the bacteria causing the infection. Meropenem is an antibiotic that kills bacteria and is used to treat patients with serious infections. When Nacubactam is combined with antibiotics, such as Meropenem, it may improve the activity against several classes of bacteria that are difficult to treat.
The study will involve adult participants with cUTI. The total duration of the study for each participant will be up to approximately 4 weeks: Screening - Up to 1 Day,In-Clinic Period: Day ( − 1), or as of Day 1, discharge on Days 3 to 14 and Follow-up Visits on Day 7 and 14 after the last dose of study drug.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0386
Date of REC Opinion
14 Nov 2017
REC opinion
Further Information Favourable Opinion