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临床试验/CTRI/2024/01/061533
CTRI/2024/01/061533尚未招募不适用

Pattern of sensitivity and resistance of stool surveillance over 13 years in a tertiary cancer centre and impact of stool surveillance guided selection of antibiotics during neutropenic sepsis in patients undergoing allogeneic HSCT

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2024年1月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
358
试验地点
1
主要终点
-Time to defervescence in all groups Pansensitive, ESBL, MDR,VRE

研究概览

简要总结

Introduction

The human gut contains a diverse range of bacteria which have many varied functions. The functions include maintaining a healthy gut immune system and killing harmful microorganisms.

Allogeneic hematopoietic stem cell transplant (HSCT) involves use of high dose chemotherapy and radiotherapy which damages the gut tissue and predisposes patients to infections and gut graft versus host disease.

A significant proportion of allogeneic HSCT patients will develop bacterial infections which leads to prolonged hospital stay and sometimes death. There is a worldwide rise in infections with multidrug resistant organisms. This is particularly a problem of our country where we have seen a steady rise in multidrug resistant organism infections.

There is a need to minimize the upfront use of higher antibiotics in all HSCT patients to restrict the development of antibiotic resistance.

 What is the rationale of this trial?

In our unit we send stool surveillance cultures in all our patients undergoing allogeneic HSCT weekly. Antibiotic strategy during the episode of fever in pre-engraftment period in HSCT patients can be of two type i.e. empirical or based on the pretransplant surveillance stool cultures.

Empirical strategy is defined, in context, as giving an initial empirical regimen (e.g. cefeperazone and aminoglycoside, or single agent piperacillin-tazobactam) that covers most sensitive organisms. If the fever persists or if the patient deteriorates, or a resistant pathogen is isolated, therapy is ‘escalated’ to an antibiotic or a combination with a broader spectrum. On the contrary, the second strategy employs antibiotics based on the surveillance cultures.

We would like to study the stool colonization patterns in our patients undergoing allogeneic HSCT and the impact of using empirical versus stool guided antibiotic policy on the fever episodes of these patients.

We would also like to study the pattern of stool sensitivity in our HSCT patients over the last 13 years to better understand the emergence of multi drug resistant organisms.

With the above-mentioned facts and hypothesis, we propose a retrospective analysis of all the allogenic hematopoietic stem cell transplants done at our centre from January 2008 to December 2020, analyzing the Pattern of sensitivity and resistance of stool surveillance over 13 years in a tertiary cancer centre and impact of stool surveillance guided selection of antibiotics during neutropenic sepsis in patients undergoing allogeneic HSCT.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients admitted for allogenic hematopoietic stem cell transplant from January 2008 to December 2020.

排除标准

  • Patients having active gastrointestinal bleed at the time of allogenic hematopoietic stem cell transplant.

结局指标

主要结局

-Time to defervescence in all groups Pansensitive, ESBL, MDR,VRE

时间窗: 3 months

-Time to defervescence according to empirical antibiotic use versus surveillance stool culture guided 1st line antibiotics

时间窗: 3 months

次要结局

  • -Time to change to second line antibiotics.(-Concordance rate between blood culture during first febrile neutropenia episode and baseline stool surveillance culture.)

研究者

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

Dr Akanksha Chichra

Advanced Centre for Treatment Research and Education in Cancer

研究点 (1)

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