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

NCT04395365 | Unknown Phase 3 DMC

• 1 other identifier: 17/0894
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival

  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)

Secondary Outcomes (16)

• Spontaneous Bacterial peritonitis

  Minimum period of 18 months from randomisation

• Hospital admissions

  Minimum period of 18 months from randomisation

• C. difficile-associated diarrhoea

  Minimum period of 18 months from randomisation

• Infections other than spontaneous bacterial peritonitis with hospital admission

  Minimum period of 18 months from randomisation

• Cirrhosis related events

  Minimum period of 18 months from randomisation

Study Arms (2)

Co-trimoxazole

EXPERIMENTAL

Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months

Drug: Co-Trimoxazole 960Mg Dispersible Tablet

Placebo

PLACEBO COMPARATOR

Placebo, 960mg capsule oral tablet, to be taken daily for 18 months

Drug: Placebo oral tablet

Interventions

Co-Trimoxazole 960Mg Dispersible Tablet DRUG

Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis

Co-trimoxazole

Placebo oral tablet DRUG

Placebo

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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\*
• Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter\*
• 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

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Free hospital

Hampstead, London, NW3 2QG, United Kingdom

Location

MeSH Terms

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 20, 2020
• Study Start: June 30, 2019
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)