ASEPTIC - using co-trimoxazole antibiotics to prevent spontaneous bacterial peritonitis in cirrhosis

Phase 1

• Conditions: Spontaneous bacterial peritonitis infection in patients with advanced liver disease; MedDRA version: 20.1Level: LLTClassification code 10061135Term: Spontaneous bacterial peritonitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-000581-38-GB
• Lead Sponsor: niversity College London Comprehensive Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 548

Inclusion Criteria

1.Patients with liver cirrhosis and ascites with ascitic fluid protein count <2.0 g/dL (from sample taken within 12 weeks prior to randomisation)
2.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)
3.Patient at least 18 years of age
4.Documented informed consent to participate

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 438
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1.Patients with previous Spontaneous Bacterial Peritonitis (SBP)
2.Patients receiving palliative care with an expected life expectancy of <8 weeks
3.Allergic to co-trimoxazole, trimethoprim or sulphonamides
4.Pregnant or lactating mothers
5.Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
6.Patients with persistent hyperkalaemia (>6.5 mmol/L) related to pre-existing kidney disease that is not possible to reduce
7.Patients receiving antibiotic prophylaxis (except for rifaximin)
8.Patients with long-term ascites drains
9.Women of child bearing potential and males with a partner of child bearing potential without effective contraception for the duration of trial treatment;
10.Severe thrombocytopaenia defined as platelets <30 x109/L
11.Any clinical condition which the investigator considers would make the patient unsuitable for the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified