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临床试验/CTRI/2024/02/062539
CTRI/2024/02/062539招募中4 期

Efficacy of Triple vs Double drug regimens with at least two sensitive antibiotics on the outcome of patients infected with ventilator-associated pneumonia due to carbepenam-resistant Acinetobacter Baumannii: A randomised controlled study.

AIIMS JODHPUR1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
AIIMS JODHPUR
入组人数
174
试验地点
1
主要终点
Comparison of 28-day all-cause mortality between triple and

研究概览

简要总结

The present randomised controlled single-blinded study shall be conducted in adult intensive care at AIIMS JODHPUR after obtaining written informed consent from the patients/patient’s relatives and approval from the institutional ethical committee. The study shall be prospectively registered with a clinical trial registry. Adult patients admitted to the intensive care unit for the duration of our study and meeting our inclusion criterion shall be included in the study. They shall be randomised into two groups using the block randomisation technique where one group will receive dual therapy while the other will receive triple therapy containing at least two sensitive drugs in each. The dual therapy will receive either minocycline 200mg bd with sulbactam high dose if sensitive to minocycline or polymyxin with high dose sulbactam if minocycline resistant. The triple therapy regimen will receive minocycline 200mg bd with polymyxin and sulbactam irrespective of minocycline sensitivity.

The baseline APACHE 2 score and SOFA score at treatment initiation and 48 hours after initiation shall be measured. Crossover from dual to triple therapy will be considered if SOFA rises more than 2 post-treatment initiation or persistence of microbiological positivity at day 4 from treatment initiation.

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 75.00 Year(s)(—)
性别
All

入选标准

  • Having ventilator-associated pneumonia (VAP) infection due to Carbepenam resistant A.
  • Baumannii (CRAB) during ICU stay.

排除标准

  • Consent not obtained
  • Pregnant patients
  • Not treated for the infection
  • Infection not likely
  • Allergy to any drug used in the regimen.

结局指标

主要结局

Comparison of 28-day all-cause mortality between triple and

时间窗: Comparison of 28-day all-cause mortality between triple and | dual antibiotic drug regimen for VAP infection due to CRAB.

dual antibiotic drug regimen for VAP infection due to CRAB.

时间窗: Comparison of 28-day all-cause mortality between triple and | dual antibiotic drug regimen for VAP infection due to CRAB.

次要结局

  • Microbiological clearance, length of ventilator stay, length of ICU stay, antibiotic treatment duration, in-hospital mortality, secondary infections post-CRAB infection.(During Hospital stay.)

研究者

发起方
AIIMS JODHPUR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sadik Mohammed

AIIMS, JODHPUR

研究点 (1)

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