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
See above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
442
Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis
Placebo
Royal Free hospital
Hampstead, London, United Kingdom
Overall Survival
Overall Survival
Time frame: 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)
Spontaneous Bacterial peritonitis
Time to first incidence of spontaneous bacterial peritonitis (SBP)
Time frame: Minimum period of 18 months from randomisation
Hospital admissions
Hospital admission rates
Time frame: Minimum period of 18 months from randomisation
C. difficile-associated diarrhoea
Incidence of C. difficile-associated diarrhoea
Time frame: Minimum period of 18 months from randomisation
Infections other than spontaneous bacterial peritonitis with hospital admission
Incidence of infections other than spontaneous bacterial peritonitis with hospital admission.
Time frame: Minimum period of 18 months from randomisation
Cirrhosis related events
Incidence of other cirrhosis related events (e.g. variceal haemorrhage)
Time frame: Minimum period of 18 months from randomisation
Renal dysfunction
Incidence of renal dysfunction with creatinine \>133 μmol/L (1.5mg/dL) at any point during hospital admission
Time frame: Minimum period of 18 months from randomisation
Anti-microbial resistance
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Incidence of anti-microbial resistance
Time frame: Minimum period of 18 months from randomisation
Liver transplantation
Incidence of liver transplantation
Time frame: Minimum period of 18 months from randomisation
Liver disease assessed by increase in MELD score
Progression of liver disease assessed by increase in MELD score between baseline and end of trial follow up.
Time frame: Minimum period of 18 months from randomisation
Safety and treatment-related serious adverse events
Safety and treatment-related serious adverse events
Time frame: Minimum period of 18 months from randomisation
Treatment adherence
Treatment adherence (assessed by MARS questionnaire)
Time frame: Minimum period of 18 months from randomisation
Health-related quality of life
Health-related quality of life assessed using EQ-5D-5L questionnaire
Time frame: Minimum period of 18 months from randomisation
Health and social care
Health and social care resource use assessed using Hospital Episode Statistics (HES) database
Time frame: Minimum period of 18 months from randomisation
Mean incremental cost per quality adjusted life year gained (QALY)
Mean incremental cost per quality adjusted life year gained (QALY)
Time frame: Minimum period of 18 months from randomisation
Incidence of resolution of ascites with diuretic treatment not required for 6 months
Incidence of resolution of ascites with diuretic treatment not required for 6 months
Time frame: Minimum period of 18 months from randomisation
Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Incidence of Transjugular intrahepatic portosystemic shunt (TIPS) insertion
Time frame: Minimum period of 18 months from randomisation