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

NCT02683642 | Completed

• 1 other identifier: FungalISF
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Three months from the date of admission

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

15 ICU are identified across the country where ICU physicians are well versed about invasive fungal infections and competent diagnostic mycology laboratory is available A site feasibility survey was conducted. This ensured that participating sites fulfill the following inclusion criteria: a) maintains ICD coding and total number of discharges and deaths at the center; b) manages critically ill patients in ICU; c) has access to high-resolution CT (HRCT) scans; d) has a mycology laboratory that performs isolation and identification of fungi at least perform galactomannan test; and e) has histopathology facilities. All consecutive patients with proven and probable IMI in ICUs at the study centers during the study period will be included.

You may qualify if:

• Proven:
• Histopathology/cytology/culture/direct microscopy demonstrating septate hyphae invading tissue or aspirate from sterile sites
• Probable:
• Host criteria of EORTC
• Host with COPD satisfying definitions by Bulpa P, et al Eur Resp J 2007
• Host in ICU satisfying clinical algorithm by Blot SI, et al Am J Resp Crit Care Med 2012

You may not qualify if:

• Endemic mycoses (histoplasmosis, sporotrichosis, penicilliosis)
• Yeast infections
• Allergic fungal diseases like allergic bronchopulmonary aspergillosis
• Infection limited to the skin only

Sponsors & Collaborators

• Fungal Infection Study Forum: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (11)

Sterling Hospital

Ahmedabad, Gujarat, 380052, India

Location

St.Johns Medical College

Bangalore, Karnataka, 560034, India

Location

Chirayu Medical College

Bhopal, Madhya Pradeh, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Sir Gangaram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Indraprastha Apollo Hospitals

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Sri Ramchandra Medical university

Chennai, Tamil Nadu, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Nizams Institute Of Medical Sciences

Hyderabad, Telangana, 500082, India

Location

AMRI Hospital

Kolkata, West Bengal, India

Location

PGIMER

Chandigarh, India

Location

Related Publications (1)

• Chakrabarti A, Kaur H, Savio J, Rudramurthy SM, Patel A, Shastri P, Pamidimukkala U, Karthik R, Bhattacharya S, Kindo AJ, Bhattacharya P, Todi S, Gopalakrishan R, Singh P, Pandey A, Agarwal R. Epidemiology and clinical outcomes of invasive mould infections in Indian intensive care units (FISF study). J Crit Care. 2019 Jun;51:64-70. doi: 10.1016/j.jcrc.2019.02.005. Epub 2019 Feb 5.

  PMID: 30769292 DERIVED

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Arunaloke Chakrabarti, MD, DNB

  PGIMER, Chandigarh

  STUDY DIRECTOR

• Shivaprakash M Rudramurthy, MD

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

• Randeep Guleria, MD

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

• Malini Capoor, MD

  Vardhman Mahavir Medical College, New Delhi

  PRINCIPAL INVESTIGATOR

• Arvind Baronia, MD

  SGPGI, Lucknow

  PRINCIPAL INVESTIGATOR

• Subhash Todi, MD

  AMRI Hospitals, Kolkata

  PRINCIPAL INVESTIGATOR

• Sanjay Bhattacharyya, MD

  Tata Medical Centre, Kolkata

  PRINCIPAL INVESTIGATOR

• P Umabala, MD

  NIMS, Hyderabad

  PRINCIPAL INVESTIGATOR

• Ranganathan Iyer, MD

  Global Hospital, Hyderabad

  PRINCIPAL INVESTIGATOR

• Ram Gopalakrishnan, MD

  Apollo Hspital, Chennai

  PRINCIPAL INVESTIGATOR

• Anupma J Kindo, MD

  Sri Ramchandra Medical University, Chennai

  PRINCIPAL INVESTIGATOR

• O C Abraham, MD

  CMC, Vellore

  PRINCIPAL INVESTIGATOR

• Sriram Sampath, MD

  St John Medical College, Bengaluru

  PRINCIPAL INVESTIGATOR

• Rajeev Soman, MD

  Hinduja Hospital, Mumbai

  PRINCIPAL INVESTIGATOR

• Atul Patel, MD

  Sterling Hospital, Ahmedabad

  PRINCIPAL INVESTIGATOR

• Pradip Bhattacharyya, MD

  Chirayu Medical College, Bhopal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, FISF

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: February 17, 2016
• Study Start: April 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

IN (11)