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

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Recruiting
participants needed

548
sponsor

University College, London

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Updated on 19 February 2024

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antibiotics

cirrhosis

spontaneous bacterial peritonitis

ascites

polymorphonuclear count

microbial culture

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

Details

Condition	Spontaneous Bacterial Peritonitis
Age	18years - 100years
Treatment	Placebo Oral Tablet, Co-Trimoxazole 960Mg Dispersible Tablet
Clinical Study Identifier	NCT04395365
Sponsor	University College, London
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients with liver cirrhosis and ascites with ascitic fluid protein count <2.0 g/dL (from sample taken within <12 weeks prior to randomisation)
	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)
	Patient at least 18 years of age
	Documented informed consent to participate
Exclusion Criteria
	Patients with previous Spontaneous Bacterial Peritonitis (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 persistent hyperkalaemia (>6.5 mmol/L) related to pre-existing kidney disease with reduction not possible
	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 (granulocytopenia, megaloblastic anaemia)
	Severe thrombocytopenia with a platelet count <30 x109 /L
	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

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