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临床试验/NCT07097727
NCT07097727已完成1 期

Evaluation of the Role of Acetyl Cysteine in The Treatment of Ventilator Associated Pneumonia Induced by Carbapenem Resistance Klebsiella

Tanta University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月30日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Improvement of clinical pulmonary infection score.

研究概览

简要总结

The aim of the study is to evaluate the role of addition of Acetyl cysteine in the management of VAP induced by carbapenem resistant klebsiella. The primary outcome indicator is the change in modified clinical pulmonary infection score. The secondary outcome indicator is duration of mechanical ventilation.

详细描述

Ventilator-associated pneumonia remains the most common intensive care unit infection of patients on mechanical ventilation, and is associated with substantial morbidity/mortality, a longer hospital stays, and increased healthcare costs.

Multi drug resistance bacterial infection in Ventilator-associated pneumonia patients presents a global challenge due to its increasing morbidity and mortality. Multi drug resistance is defined as acquired nonsusceptibility to at least one agent in ≥ three antimicrobial categories according to the European Center for Disease Prevention and Control, The most common (80%) Ventilator-associated pneumonia pathogens were Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae.

Klebsiella pneumoniae is a common pathogen for community-and hospital-acquired infections, such as pneumonia, urinary tract infection, and bacteremia.

Infections due to Multi drug resistance Klebsiella species Were found to be associated with high mortality and hospital outbreaks. Carbapenem-resistant Klebsiella pneumoniae is among the bacteria that the World Health Organization gives critical priority to and poses the greatest threat to human health. According to China Antimicrobial Surveillance Network, carbapenem resistance in Klebsiella pneumoniae increased rapidly from 3% in 2005 to more than 25% in 2019. In case of new drugs unavailable or not active invitro, guidelines recommend combination of drugs active invitro (o polymyxins, aminoglycosides, tigecycline or Fosfomycin) with no recommendation for or against specific combinations.

In case of severe infections caused by Carbapenem-resistant Klebsiella carrying metallo-blactamases, guidelines recommend aztreonam and ceftazidimeavibactam combination therapy. Several studies demonstrated that acetyl Cysteine when added to antibacterial agent invitro, potentiates the antibacterial compound activities. The role of acetyl cystiene antioxidant and anti-inflammatory activities is being widely investigated in viral infections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are mechanically ventilated
  • Age from 21 to 65
  • Both sexes.

排除标准

  • Patient guardians who refuse the consent • Hypersensitivity to acetyl Cysteine.
  • Extrapulmonary infection.
  • Cardiac patient with chronic heart failure
  • Patient with lung diseases (tumors, tuberculosis, ,Chronic Obstructive Pulmonary Disease, Bronchiectasis and lung fibrosis)
  • Severe immunosuppression (total leucocyte < 1000 mm3 or neutrophil < 500 cell/mm
  • Patients on steroid or immunosuppressive drugs.

研究组 & 干预措施

acetyl cysteine 600 mg

Experimental

patients received acetyl cysteine 600 mg/ 12h IV in addition to antibiotics

干预措施: acetyl cysteine 600 mg (Drug)

antibiotics and saline

Experimental

patients received only antibiotics and saline.

干预措施: antibiotics and saline. (Drug)

结局指标

主要结局

Improvement of clinical pulmonary infection score.

时间窗: 14 days

Improvement of clinical pulmonary infection score . score calculated in day 14 of treatment

次要结局

  • Duration of mechanical ventilation ventilation.(14 days)
  • mortality rate(14 days)

研究者

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

Wessam Ibrahim Elfeky

Resident

Tanta University

研究点 (1)

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