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临床试验/CTRI/2024/08/073105
CTRI/2024/08/073105尚未招募不适用

A COMPARATIVE STUDY OF CEFOTAXIME VS MEROPENEM AS EMPIRICAL TREATMENT IN SPONTANEOUS BACTERIAL PERITONITIS

JLN MEDICAL COLLEGE AJMER1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年9月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
Follow-up paracentesis after 48 hours of initiation of empirical antibiotic treatment showing reduction in neutrophil count of at least 25% or

研究概览

简要总结

•Spontaneous Bacterial Peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. Third generation cephalosporins are the recommended drugs for treating Spontaneous Bacterial Peritonitis empirically. Recent studies have shown that effectiveness of cephalosporins has decreased in community acquired and hospital acquired SBP. Meropenem is being used in treatment of drug resistant and hospital acquired SBP. This study aims to evaluate and compare the effectiveness of cefotaxime vs meropenem as empirical treatment in SBP

This study is hospital based clinical trial study at JLN hospital, Ajmer. SBP was diagnosed based on the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in liver cirrhosis patients in the absence of an intra-abdominal source of infection or malignancy. 54 subjects will be taken in study and randomized into two groups. One group will be  given cefotaxime and another group meropenem. Efficacy of antibiotic therapy will be checked with follow-up paracentesis after 48 hours of initiation of empirical antibiotic treatment showing reduction in neutrophil count of at least 25% or decrease of peritoneal fluid PMN count to < 250 cells/ mm3 and negative previously positive ascitic fluid culture. Outcome of treatment will be compared in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Liver cirrhosis patients with ascitic fluid PMN cell count greater than 250/mm3 (treatment naive).
  • 2.Age equal or greater than 18 years.
  • 3.Patient who give informed consent.

排除标准

  • 1.History of abdominal surgery within 4 weeks 2.Secondary peritonitis 3.Tuberculous peritonitis 4.Malignant ascites 5.Patients on immunosuppressants 6.AIDS patients.
  • 7.Creatinine clearance less than 50 mL/min.

结局指标

主要结局

Follow-up paracentesis after 48 hours of initiation of empirical antibiotic treatment showing reduction in neutrophil count of at least 25% or

时间窗: 2 days

Decrease of peritoneal fluid PMN count to less than 250 cells/μ and negative previously positive ascitic fluid culture.

时间窗: 2 days

次要结局

  • role of serum procalcitonin as a marker of SBP(At baseline & after 2 days)

研究者

发起方
JLN MEDICAL COLLEGE AJMER
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. RISHABH PARASHAR

JLN MEDICAL COLLEGE, AJMER

研究点 (1)

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