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

Summary

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.

Conditions

• Mycoses

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Fungal Infection Study Forum

  lead OTHER

Principal Investigators

• Arunaloke Chakrabarti, MD, DNB · PGIMER, Chandigarh

• Shivaprakash M Rudramurthy, MD · PGIMER, Chandigarh

• Randeep Guleria, MD · AIIMS, New Delhi

• Malini Capoor, MD · Vardhman Mahavir Medical College, New Delhi

• Arvind Baronia, MD · SGPGI, Lucknow

• Subhash Todi, MD · AMRI Hospitals, Kolkata

• Sanjay Bhattacharyya, MD · Tata Medical Centre, Kolkata

• P Umabala, MD · NIMS, Hyderabad

• Ranganathan Iyer, MD · Global Hospital, Hyderabad

• Ram Gopalakrishnan, MD · Apollo Hspital, Chennai

• Anupma J Kindo, MD · Sri Ramchandra Medical University, Chennai

• O C Abraham, MD · CMC, Vellore

• Sriram Sampath, MD · St John Medical College, Bengaluru

• Rajeev Soman, MD · Hinduja Hospital, Mumbai

• Atul Patel, MD · Sterling Hospital, Ahmedabad

• Pradip Bhattacharyya, MD · Chirayu Medical College, Bhopal

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-09-30

Completion

2017-09-30

Countries

• India

Study Locations