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临床试验/NCT02683642
NCT02683642已完成不适用

Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome

Fungal Infection Study Forum11 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
420
试验地点
11
主要终点
Incidence of Invasive mould infections (IMIs) in Indian ICUs (Number of patients with IMI per 1000 ICU admissions)

研究概览

简要总结

Invasive mould infections are emerging causes of morbidity and mortality in ICU patients. This is attributed to prolonged ICU stay of critically ill patients with many co-morbidities. Modern medicine and multiple intervention make the patients susceptible to these prevalent moulds in the environment. In India the high frequency of IMIs in general has been attributed to environmental and host factors prevalent in this region. Additionally sub-optimal hospital care practice, frequent demolition and construction activities in the hospital make the patients susceptible to IMIs. There is no multicentric study available in India describing the epidemiology of IMIs in India. However, single center studies have reported distinct epidemiology of IMIs in India. High incidence, different spectrum and risk factors are possible unique features of IMIs in India.Early diagnosis and optimal therapy improve the outcome of these patients. The conventional diagnosis including histopathology and culture has limitations. The tests are of low sensitivity and long turnaround time. The major challenge is collection of sample from deep tissue. Therefore majority of the patients in ICUs of India are managed empirically against invasive fungal diseases. The galactomannan test has improved the diagnosis of invasive aspergillosis. However, galactomannan test is not well standardized in non-neutropenic patients. Beta-glucan test is used for early diagnosis of invasive fungal infections other than mucormycosis. But the test is cumbersome for routine laboratories and expensive. Both tests are not available in majority of Institutions of India. PCR assay is not standardized and not performed routinely in any Institution.

Due these limitations in diagnosis, there is no uniform management protocol in ICUs of India. To develop optimal management protocol, we need to know the epidemiology, the right patient to treat, antifungal drug resistance, optimal drug and duration of therapy etc. The present study will provide descriptive epidemiology, present status of diagnosis and management practiced in India to treat IMIs in ICUs. This will help to find the suitable intervention strategies to improve outcome of IMIs in India.This descriptive observational prospective study will document the epidemiologic and clinical characteristics, as well as treatment and outcome data, of patients with IMIs in ICUs in India over one year.

详细描述

The prospective study will describe the epidemiology of IMIs in ICUs in India. The study will describe the incidence, risk factors, fungi causing IMIs and their susceptibility against antifungal agents, as well as the current strategies adopted by ICU physicians in the management of IMIs. It will also describe the outcome of IMIs. The study will help in planning future management strategies specific for IMIs in ICUs in India.

Methods

Study description: Prospective, multicenter study in iCUs in India.

Purpose: Determination of epidemiologic parameters, including risk factors, description of current management and outcome of patients with IMI will be recorded prospectively. The study will help in understanding the epidemiology of IMI in ICUs and possible planning for future management strategies for IMI specific to India.

Risk: There is no risk to the patient from the study as it is only an observational study and no intervention is intended.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of Invasive mould infections (IMIs) in Indian ICUs (Number of patients with IMI per 1000 ICU admissions)

时间窗: Three months from the date of admission

次要结局

  • Incidence in specific population (Number of patients with IMI in specific population per 1000 ICU admissions)(six months after the completion of the study)
  • Mortality (number of deaths per 1000 ICU admissions)(six months after the completion of the study)

研究者

发起方
Fungal Infection Study Forum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arunaloke Chakrabarti

Chairman, FISF

Fungal Infection Study Forum

研究点 (11)

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