Mycoses Clinical Trial
Official title:
Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome
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.
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.
Site selection: 15 ICU's 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.
Study Period: April 1, 2016 to June 30, 2017. Case enrolment - April 1, 2016 to March 31,
2017. Analysis of data - April 1, 2017 to June 30, 2017
No. of patients: All consecutive patients with proven and probable IMI in ICUs at the study
centers during the study period will be included.
Patient selection All consecutive patients diagnosed for proven or probable IMIs in ICUs at
the study sites will be included.
Inclusion criteria:
Proven:
Histopathology/cytology/culture/direct microscopy demonstrating septate hyphae invading
tissue or aspirate from sterile sites
Probable:
- Host satisfies 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
Conduct of the study
Investigators of the study: Arunaloke Chakrabarti will be the coordinator of the study. Each
site will have a Principal Investigator - the site PI. Other investigators at the site will
be co-investigators.
Patient enrollment: The site PI (or one of the co-investigators) will review the patient's
paper and electronic records to determine if the patient satisfies the inclusion criteria.
Patients who fulfill the inclusion criteria will be included as a case.
Data collection: The demographic, clinical, treatment and outcome data will be collected by
investigator and email the form to the study coordinator, Arunaloke Chakrabarti. Outcome will
be measured on day of discharge/death/30 and 120 days (whichever is earlier) after the
diagnosis of the IMI. The date of diagnosis of an IMI is the day on which the diagnosis is
defined as proven or probable. For cases that were enrolled as probable but subsequently
became proven, the date of diagnosis is the earlier date. In addition, each center will also
obtain data from its relevant hospital authority on the total number of discharges and deaths
in ICUs for the period of April 1, 2016 to March 31, 2017.
Fungal isolates: All isolates from proven and probable IMIs will be sent to Mycology
Reference Laboratory at PGIMER, Chandigarh for final identification and antifungal
susceptibility testing
Patient management: The study will not interfere with patient management.
Statistics
The study will be analyzed using descriptive statistics. It is anticipated that the study
will provide the following information:
- Incidence of IMI among patients in ICUs during the study period in the participating
centers
- Relative frequency of each risk factor among IMI patients at the participating centers.
- Three-month survival of patients diagnosed with IMI.
- Other data the study should be able to generate will be in accordance with the
objectives.
- Kaplan-Meier plots will be used to describe the survival of patients with IMI according
to their underlying diagnosis.
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