A trial of using antibiotics to prevent infection in patients with advanced liver disease
- Conditions
- Spontaneous Bacterial Peritonitis (SBP) in adults with liver cirrhosis and ascitesDigestive System
- Registration Number
- ISRCTN33225996
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 442
Current participant inclusion criteria as of 13/05/2021:
1. Liver cirrhosis and ascites persisting for >3 months despite standard treatment
2. Aged =18 years
3. Documented informed consent to participate
Previous participant inclusion criteria:
1. Liver cirrhosis and ascites with ascitic fluid protein count <2.0 g/dL (from sample taken within <12 weeks prior to randomisation)
2. 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. At least 18 years of age
4. Documented informed consent to participate
Current participant exclusion criteria as of 13/05/2021:
1. Current or previous Spontaneous Bacterial Peritonitis (defined as ascitic polymorphonuclear cell count >250/mm³ with either positive or negative ascitic fluid culture without an 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. Receiving palliative care with a life expectancy of <8 weeks
3. Allergic to co-trimoxazole, trimethoprim or sulphonamides
4. Pregnant or lactating mothers
5. Enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
6. Serum potassium (>5.5 mmol/l) related to pre-existing kidney disease which cannot be reduced
7. Receiving antibiotic prophylaxis (except for rifaximin)
8. 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:
10.1. Haemoglobin (Hb) <70 g/l
10.2. Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter
10.3. Severe thrombocytopenia with a platelet count <30 x10?/l
11. Severe renal impairment, with eGFR <15 ml/min
12. Skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
13. Congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich
14. Acute porphyria
15. Any clinical condition which the investigator considers would make the patient unsuitable for the trial
As some investigations may change in patients with cirrhosis and long-term ascitic drains may be removed, patients can be re-screened for eligibility if this occurs.
Previous participant exclusion criteria:
1. Previous Spontaneous Bacterial Peritonitis (SBP)
2. 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. Enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
6. Persistent hyperkalaemia (>6.5 mmol/L) related to pre-existing kidney disease with reduction not possible
7. Receiving antibiotic prophylaxis (except for rifaximin)
8. 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. Pathological blood count changes (granulocytopenia, megaloblastic anaemia)
11. Severe thrombocytopenia with a platelet count <30 x109 /L
12. Severe renal impairment, with eGFR <15 ml/min
13. Skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
14. Congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich
15. Acute porphyria
16. Any clinical condition which the investigator considers would make the patient unsuitable for the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method