ISRCTN33225996进行中（未招募）3 期
Primary Antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis
niversity College London0 个研究点目标入组 442 人开始时间: 2020年4月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 442
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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