Status:
UNKNOWN
Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Spontaneous Bacterial Peritonitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 bacteri...
Detailed Description
See above
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich
- Patients with acute porphyria
- 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.
Exclusion
Key Trial Info
Start Date :
June 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT04395365
Start Date
June 30 2019
End Date
October 1 2025
Last Update
November 18 2023
Active Locations (1)
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1
Royal Free hospital
Hampstead, London, United Kingdom, NW3 2QG