Table 1 Eligibility criteria for ASEPTIC trial

Patients with cirrhosis of Child–Pugh class B or C and the presence of ascites requiring any diuretic treatment or at least one or more paracentesis within 3 months prior to enrolment

Patients with current or previous SBP (defined as ascitic polymorphonuclear count > 250 cells/mm³ with either positive or negative ascitic fluid culture without an evident intra-abdominal surgically treatable source of infection; a white cell count > 500 cell/mm³ or positive microbial culture may be considered as evidence of previous SBP if the site PI considers this was in the context of a likely clinical diagnosis of SBP)

At least 18 years of age

Patients receiving palliative care with an expected life expectancy of < 8 weeks

Documented informed consent to participate

Allergy to co-trimoxazole, trimethoprim, or sulphonamides

Pregnant or lactating mothers

Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact their participation in the study

Patients with serum potassium > 5.5 mmol/L related to pre-existing kidney disease which cannot be reduced^a

Patients receiving antibiotic prophylaxis (except rifaximin)^a

Patients with long-term ascite drains^a

Women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of the trial treatment

Patients with pathological blood count changes^a: haemoglobin < 70 g/L, granulocytopaenia defined as absolute neutrophil count < 500 cells/µL, and/or severe thrombocytopaenia with platelets < 30 × 10⁹/L

Patients with severe renal impairment, with eGFR < 15 mL/min

Patients with skin conditions: exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug eruption with eosinophilia and systemic symptoms

Patients with congenital conditions: congenital glucose-6-phosphate dehydrogenase deficiency of the erythrocytes and haemoglobin anomalies such as Hb Köln and Hb Zürich

Patients with acute porphyria

Any clinical condition which the investigator considers would make the patient unsuitable for the trial