UnknownPhase 3

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

United Kingdom442 participantsStarted 2019-06-30

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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\*

What they're measuring

Overall Survival

Timeframe: 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)

Trial details

NCT IDNCT04395365

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

View on ClinicalTrials.gov More Spontaneous Bacterial Peritonitis trials