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

NCT ID: NCT04395365

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2025-10-31

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

Detailed Description

See above

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Co-trimoxazole

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

Group Type: EXPERIMENTAL

Co-Trimoxazole 960Mg Dispersible Tablet

Intervention Type: DRUG

Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo

Interventions

Co-Trimoxazole 960Mg Dispersible Tablet

Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis

Intervention Type: DRUG

Placebo oral tablet

Placebo

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient at least 18 years of age

3. Documented informed consent to participate

Exclusion Criteria

1. 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).

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 serum potassium (>5.5 mmol/L) related to pre-existing kidney disease which cannot be reduced*

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. Patients with pathological blood count changes

1. Patients with haemoglobin (Hb) <70g/L*

2. Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter*

3. Severe thrombocytopenia with a platelet count <30 x109 /L*

11. Patients with severe renal impairment, with eGFR <15 ml/min*

12. Patients with skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms

13. Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich

14. Patients with acute porphyria

15. Any clinical condition which the investigator considers would make the patient unsuitable for the trial.

• It is common for these investigations to change in patients with cirrhosis and long-term ascitic drains may be removed. Patients can be re-screened for eligibility if this occurs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Free hospital

Hampstead, London, United Kingdom

Countries

United Kingdom

Other Identifiers

17/0894

Identifier Type: -

Identifier Source: org_study_id