Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis

  • End date
    Oct 16, 2024
  • participants needed
  • sponsor
    University College, London
Updated on 16 October 2021


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

Condition Spontaneous Bacterial Peritonitis
Treatment Placebo Oral Tablet, Co-Trimoxazole 960Mg Dispersible Tablet
Clinical Study IdentifierNCT04395365
SponsorUniversity College, London
Last Modified on16 October 2021


Yes No Not Sure

Inclusion Criteria

Patients with Child-Pugh Class B or C cirrhosis and presence of ascites requiring any diuretic treatment or at least 1 or more paracentesis within 3 months prior to enrolment
Patient at least 18 years of age
Documented informed consent to participate

Exclusion Criteria

Patients with current or previous Spontaneous Bacterial Peritonitis (defined as ascitic polymorphonuclear (PMN) cell count >250/mm3 with either positive or negative ascitic fluid culture without evident intra-abdominal surgically treatable source of infection. A white cell count >500 cell/mm2 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)
Patients receiving palliative care with an expected life expectancy of <8 weeks
Allergic to co-trimoxazole, trimethoprim or sulphonamides
Pregnant or lactating mothers
Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
Patients with serum potassium (>5.5 mmol/L) related to pre-existing kidney disease which cannot be reduced
Patients receiving antibiotic prophylaxis (except for rifaximin)
Patients with long-term ascites drains
Women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of trial treatment
Patients with pathological blood count changes
Patients with haemoglobin (Hb) <70g/L
Severe thrombocytopenia with a platelet count <30 x109 /L
Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter
Patients with severe renal impairment, with eGFR <15 ml/min
Patients with skin conditions: exudative erythema multiform, 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, haemoglobin anomalies such as Hb Kln and Hb Zrich
Patients with acute porphyria
Any clinical condition which the investigator considers would make the patient unsuitable for the trial
It is common for these investigations to change in patients with cirrhosis and long-term ascitic drains may be removed. Patients can be re-screened for eligibility if this occurs
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