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

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

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

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

Summary

Details

How to participate?

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note

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

Summary

Details

How to participate?

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Sign up as a volunteer to stay informed

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note