Spontaneous bacterial peritonitis infection in patients with advanced liver disease MedDRA version: 20.1 Level: LLT Classification code 10061135 Term: Spontaneous bacterial peritonitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Co-trimoxazole 960mg
Product Name: Co-trimoxazole 960mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Trimethoprim
CAS Number: 738-70-5
Concentration unit: mg milligram(s)
Concentrati
Sponsors
University College London Comprehensive Clinical Trials Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients with liver cirrhosis and ascites with ascitic fluid protein count =65 years) no F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients with previous Spontaneous Bacterial Peritonitis (SBP) 2. Patients receiving palliative care with an expected life expectancy of 6.5 mmol/L) related to pre-existing kidney disease that is not possible to reduce 7. Patients receiving antibiotic prophylaxis (except for rifaximin) 8. Patients with long-term ascites drains 9. Women of child bearing potential and males with a partner of child bearing potential without effective contraception for the duration of trial treatment; 10. Severe thrombocytopaenia defined as platelets <30 x109/L 11. Any clinical condition which the investigator considers would make the patient unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether primary antibiotic prophylaxis with co-trimoxazole reduces the incidence of spontaneous bacterial peritonitis compared to placebo in adults with cirrhosis and ascites. The time to first incidence of spontaneous bacterial peritonitis up to 24 months following randomisation will be measured.;Secondary Objective: The following will be measured up to 24 months from randomisation: 1. All-cause mortality 2. Hospital admission with incidence of spontaneous bacterial peritonitis 3. Hospital admission rates 4. Hospital admission with incidence of C. difficile-associated diarrhoea 5. Documented incidence of antimicrobial resistance defined as infections during hospital admission with bacteria resistant to standard antibiotic treatment 6. Other infections including respiratory tract, urinary tract, cellulitis, bacteraemia, cerebral infections and infections with uncertain sources 7. Other cirrhosis related events (e.g. variceal haemorrhage) 8. Complications relating to SBP including Intensive Care Unit admission and renal dysfunction with creatinine >133 µmol/L (1.5mg/dL) at any point during hospital admission 9. Incidence of liver transplantation 10. Progression of liver disease assessed by Model for End-Stage Liver Disease (MELD) score. The MELD score is a scoring system for assessing the severit;Primary end point(s): The primary outcome will be the difference in the time to the first incidence of spontaneous bacterial peritonitis (SBP) infecion ;Timepoint(s) of evaluation of this end point: 24 months following randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. All-cause mortality 2. Hospital admission with incidence of spontaneous bacterial peritonitis 3. Hospital admission rates 4. Hospital admission with incidence of C. difficile-associated diarrhoea 5. Documented incidence of antimicrobial resistance defined as infections during hospital admission with bacteria resistant to standard antibiotic treatment. 6. Other infections including respiratory tract, urinary tract, cellulitis, bacteraemia, cerebral infections and infections with uncertain sources 7. Other cirrhosis related events (e.g. variceal haemorrhage) 8. Complications relating to SBP including ICU admission and renal dysfunction with creatinine >133 µmol/L (1.5mg/dL) at any point during hospital admission 9. Incidence of liver transplantation 10. Progression of liver disease assessed by MELD score 11. Safety and treatment-related adverse events 12. Treatment adherence (assessed at dispensing) 13. Health-related quality of life assessed using EQ-5D-5L questionnaire 14. Health and social care resource use assessed using Hospital Episode Statistics (HES) database 15. Mean incremental cost per quality adjusted life year gained (QALY) 16. Resolution of ascites with diuretic treatment not required for 6 months All the above outcomes are assessed up to 24 months following randomisation.;Timepoint(s) of evaluation of this end point: As per protocol. Visit 1 - Month 0 Visit 3 - Month 1 Visit 4 - Month 3 Visit 5 - Mont 6 Visit 7 - Month 12 Visit 8 - Month 15 Visit 9 - Month 18 Visit 10 - Month 21 Visit 11 - Month 24 | — |
Countries
United Kingdom
Contacts
Public ContactDaizy Moualeu Kameni
University College London
Outcome results
None listed