CREDIBLE
Research type
Research Study
Full title
A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
IRAS ID
200545
Contact name
Anna Goodman
Contact email
Sponsor organisation
Shionogi Ltd.
Eudract number
2015-004703-23
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Infections caused by multidrug-resistant bacteria are an increasing occurrence observed worldwide and a growing unmet medical need. One group of bacteria known as Gram-negative bacteria can cause infections of the lung (pneumonia), blood-stream infections/sepsis, and the urinary tract infections among other organs. Doctors use antibiotics to treat these infections but sometimes these antibiotics do not succeed as the bacteria develop resistance to antibiotic effects. Sometimes the bacteria develop resistance to a group of antibiotics called carbapenems, currently one of the last resources to treat these infections. When resistance to carbapenems occurs, there are few alternative treatments available to treat very sick patients.
This clinical study will evaluate how safe and how effective the study medication S-649266 is and compare it to the best available therapy (BAT). The BAT is the standard of care treatment available at the institution that a doctor would use to treat the patient if they do not take part in the study.
The study will enrol adult hospitalised patients with either hospital acquired pneumonia/ ventilator associated pneumonia/ healthcare-associated pneumonia, blood-stream infections/sepsis or complicated urinary tract infection caused by a gram-negative pathogen with evidence of carbapenem-resistance.
Participants who take part in the study will receive treatment in the hospital for 7-14 days with either study medication S-649266 (Cefiderocol) or BAT. Based on the investigator’s clinical assessment of the patient, treatment may be extended up to 21 days. Worldwide approximately 150 participants will be enrolled and randomised 2:1 to S-649266 and BAT, meaning that approximately 100 participants will be treated with S-649266 and 50 participants with BAT. Participants will receive study medication S-649266 into a vein over a period of 3 hours, every 8 hours. After treatment, participants will be followed-up for approximately 28 days from end of treatment. The total study duration for individual participants is approximately 5 to 7 weeks.REC name
London - South East Research Ethics Committee
REC reference
17/LO/0100
Date of REC Opinion
21 Apr 2017
REC opinion
Further Information Favourable Opinion