Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
- Conditions
- Spontaneous Bacterial Peritonitis
- Interventions
- Drug: Co-Trimoxazole 960Mg Dispersible TabletDrug: Placebo oral tablet
- Registration Number
- NCT04395365
- Lead Sponsor
- University College, London
- Brief 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
- Detailed Description
See above
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 442
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Co-trimoxazole Co-Trimoxazole 960Mg Dispersible Tablet Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months Placebo Placebo oral tablet Placebo, 960mg capsule oral tablet, to be taken daily for 18 months
- Primary Outcome Measures
Name Time Method Overall Survival The maximum possible period of follow up will be 48 months (assuming a recruitment period of 30 months and 18 months treatment period for final patient recruited) Overall Survival
- Secondary Outcome Measures
Name Time Method Infections other than spontaneous bacterial peritonitis with hospital admission Minimum period of 18 months from randomisation Incidence of infections other than spontaneous bacterial peritonitis with hospital admission.
Spontaneous Bacterial peritonitis Minimum period of 18 months from randomisation Time to first incidence of spontaneous bacterial peritonitis (SBP)
Hospital admissions Minimum period of 18 months from randomisation Hospital admission rates
C. difficile-associated diarrhoea Minimum period of 18 months from randomisation Incidence of C. difficile-associated diarrhoea
Cirrhosis related events Minimum period of 18 months from randomisation Incidence of other cirrhosis related events (e.g. variceal haemorrhage)
Renal dysfunction Minimum period of 18 months from randomisation Incidence of renal dysfunction with creatinine \>133 μmol/L (1.5mg/dL) at any point during hospital admission
Anti-microbial resistance Minimum period of 18 months from randomisation Incidence of anti-microbial resistance
Liver transplantation Minimum period of 18 months from randomisation Incidence of liver transplantation
Liver disease assessed by increase in MELD score Minimum period of 18 months from randomisation Progression of liver disease assessed by increase in MELD score between baseline and end of trial follow up.
Safety and treatment-related serious adverse events Minimum period of 18 months from randomisation Safety and treatment-related serious adverse events
Treatment adherence Minimum period of 18 months from randomisation Treatment adherence (assessed by MARS questionnaire)
Health-related quality of life Minimum period of 18 months from randomisation Health-related quality of life assessed using EQ-5D-5L questionnaire
Mean incremental cost per quality adjusted life year gained (QALY) Minimum period of 18 months from randomisation Mean incremental cost per quality adjusted life year gained (QALY)
Health and social care Minimum period of 18 months from randomisation Health and social care resource use assessed using Hospital Episode Statistics (HES) database
Incidence of resolution of ascites with diuretic treatment not required for 6 months Minimum period of 18 months from randomisation Incidence of resolution of ascites with diuretic treatment not required for 6 months
Transjugular intrahepatic portosystemic shunt (TIPS) insertion Minimum period of 18 months from randomisation Incidence of Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Trial Locations
- Locations (1)
Royal Free hospital
🇬🇧Hampstead, London, United Kingdom