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临床试验/NCT05427747
NCT05427747Unknown4 期

Meropenem vs Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis :Prospective Randomized Clinical Trial

Assiut University0 个研究点目标入组 286 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
286
主要终点
Response to treatment within 5 days

研究概览

简要总结

We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically.

详细描述

Ascites is the most frequent complication of cirrhosis and represents a significant change for the patient because the impact on mortality and quality of life is important.

Spontaneous bacterial peritonitis (SBP) is a dreaded complication in patients with decompensated cirrhosis.

Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.

Spontaneous bacterial peritonitis carries a mortality rate of 30 to 70% in patients with end-stage liver and kidney disease.

Choice of antibiotic is dependent on type of microbes responsible for infection. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. This is the reason, 3rd generation cephalosporins are the recommended drugs of choice for treating SBP empirically. But recent studies have shown that Cephalosporins are effective only in 70% of community acquired and 56% of hospital acquired SBP.It is most likely due to changing bacterial pathogens of SBP over last two decades as now gram positive bacteria and multi drug resistance organism (MDRO) are increasingly being isolated in SBP. It is the consequence of undue, over the counter misuse of cephalosporins in community and frequent exposure of cirrhosis patients to these drugs during recurrent hospital admissions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Liver cirrhosis patients with ascites Ascitic fluid PMN cell count >250/mm3 Age: 18:80

排除标准

  • : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, Malignant tumor, patients who use hormones or immunosuppressants, AIDS patients.

研究组 & 干预措施

cefotaxime

Experimental

ceotaxime 2g iv /8hr

干预措施: cefotaxime (Drug)

meropenem

Experimental

meropenem 1g iv /8hr

干预措施: cefotaxime (Drug)

结局指标

主要结局

Response to treatment within 5 days

时间窗: 5 days

The response to therapy is defined as the reduction of polymorphonuclear leukocytes (PMN) count in ascitic fluid more than 25 % from baseline after 48 hours and as a PMN count in ascitic fluid less then 250/mm³ after 5 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taha Hussein Kawashty Abdelrahman

doctor

Assiut University

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