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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683642
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Arunaloke Chakrabarti, Fungal Infection Study Forum

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.


Condition or disease
Mycoses

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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome
Actual Study Start Date : April 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of Invasive mould infections (IMIs) in Indian ICUs (Number of patients with IMI per 1000 ICU admissions) [ Time Frame: Three months from the date of admission ]

Secondary Outcome Measures :
  1. Incidence in specific population (Number of patients with IMI in specific population per 1000 ICU admissions) [ Time Frame: six months after the completion of the study ]
  2. Mortality (number of deaths per 1000 ICU admissions) [ Time Frame: six months after the completion of the study ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683642


Locations
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India
Sir Gangaram Hospital
New Delhi, Delhi, India, 110060
Indraprastha Apollo Hospitals
New Delhi, Delhi, India, 110076
Sterling Hospital
Ahmedabad, Gujarat, India, 380052
St.Johns Medical College
Bangalore, Karnataka, India, 560034
Chirayu Medical College
Bhopal, Madhya Pradeh, India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sri Ramchandra Medical university
Chennai, Tamil Nadu, India
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Nizams Institute Of Medical Sciences
Hyderabad, Telengana, India, 500082
AMRI Hospital
Kolkata, West Bengal, India
PGIMER
Chandigarh, India
Sponsors and Collaborators
Fungal Infection Study Forum
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Arunaloke Chakrabarti, MD, DNB PGIMER, Chandigarh
Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arunaloke Chakrabarti, Chairman, FISF, Fungal Infection Study Forum
ClinicalTrials.gov Identifier: NCT02683642    
Other Study ID Numbers: FungalISF
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Mycoses