Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
Who is this study for? Patients with liver cirrhosis
What treatments are being studied? Co-Trimoxazole
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with Child-Pugh Class B or C cirrhosis and presence of ascites requiring any diuretic treatment or at least 1 or more paracentesis within 3 months prior to enrolment.
• Patient at least 18 years of age
• Documented informed consent to participate
Locations
Other Locations
United Kingdom
Royal Free hospital
Hampstead
Time Frame
Start Date: 2019-06-30
Completion Date: 2025-10
Participants
Target number of participants: 442
Treatments
Experimental: Co-trimoxazole
Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months
Placebo_comparator: Placebo
Placebo, 960mg capsule oral tablet, to be taken daily for 18 months
Authors
Alistair O'Brien
Related Therapeutic Areas
Sponsors
Leads: University College, London
Collaborators: National Institute for Health Research, United Kingdom