Overview

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

Eligibility

Inclusion Criteria:

1. Patients with liver cirrhosis and ascites with ascitic fluid protein count <2.0 g/dL (from sample taken within <12 weeks prior to randomisation)
2. Patients with ascitic polymorphonuclear count <250 cells/mm3 and negative microbial culture at 5 days (on the last sample sent within <12 weeks prior to randomisation)
3. Patient at least 18 years of age
4. Documented informed consent to participate

Exclusion Criteria:

1. Patients with previous Spontaneous Bacterial Peritonitis (SBP)
2. Patients receiving palliative care with an expected life expectancy of <8 weeks
3. Allergic to co-trimoxazole, trimethoprim or sulphonamides
4. Pregnant or lactating mothers
5. Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
6. Patients with persistent hyperkalaemia (>6.5 mmol/L) related to pre-existing kidney disease with reduction not possible
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. Patients with pathological blood count changes (granulocytopenia, megaloblastic anaemia)
11. Severe thrombocytopenia with a platelet count <30 x109 /L
12. Patients with severe renal impairment, with eGFR <15 ml/min
13. Patients with skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
14. Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Kln and Hb Zrich
15. Patients with acute porphyria
16. Any clinical condition which the investigator considers would make the patient unsuitable for the trial