MycosesNCT02683642
Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome
An observational study of Mycoses, run by Fungal Infection Study Forum at 11 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycoses
- How many people
- 420 participants
- Where
- 11 sitesIndia
- Study dates
- Apr 2016to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Endemic mycoses (histoplasmosis, sporotrichosis, penicilliosis)
- Yeast infections
- Allergic fungal diseases like allergic bronchopulmonary aspergillosis
- Infection limited to the skin only
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Sterling Hospital
Ahmedabad, Gujarat, 380052
St.Johns Medical College
Bangalore, Karnataka, 560034
Chirayu Medical College
Bhopal, Madhya Pradeh
PGIMER
Chandigarh
Sri Ramchandra Medical university
Chennai, Tamil Nadu
Nizams Institute Of Medical Sciences
Hyderabad, Telangana, 500082
AMRI Hospital
Kolkata, West Bengal
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Sir Gangaram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Christian Medical College
Vellore, Tamil Nadu, 632004
About this study
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.
Read the detailed description
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.
- Conditions
- Mycoses
- Medical subject headings
- Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Invasive mould infections (IMIs) in Indian ICUs (Number of patients with IMI per 1000 ICU admissions)
Measured: 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)
Measured: six months after the completion of the study
Mortality (number of deaths per 1000 ICU admissions)
Measured: six months after the completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MycosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fungal Infection Study Forum
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Arunaloke Chakrabarti, Fungal Infection Study Forum
- Investigators
- Arunaloke Chakrabarti, MD, DNB, Study director, PGIMER, ChandigarhShivaprakash M Rudramurthy, MD, Principal investigator, PGIMER, ChandigarhRandeep Guleria, MD, Principal investigator, All India Institute of Medical SciencesMalini Capoor, MD, Principal investigator, Vardhman Mahavir Medical College, New DelhiArvind Baronia, MD, Principal investigator, SGPGI, LucknowSubhash Todi, MD, Principal investigator, AMRI Hospitals, KolkataSanjay Bhattacharyya, MD, Principal investigator, Tata Medical Centre, KolkataP Umabala, MD, Principal investigator, NIMS, Hyderabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683642
- Sponsor's protocol ID
- FungalISF
- Status last verified
- Feb 2018
- First submitted
- 21 Dec 2015
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30769292
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Mould Infections in Indian ICUs - Descriptive Epidemiology, Management and Outcome
- ClinicalTrials.gov ID
- NCT02683642
- Acronym / sponsor ID
- FungalISF
- Conditions
- Mycoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Fungal Infection Study ForumUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Histopathology/cytology/culture/direct microscopy demonstrating septate hyphae invading tissue or aspirate from sterile sites
- 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
Key exclusion criteria (4 listed)
- Endemic mycoses (histoplasmosis, sporotrichosis, penicilliosis)
- Yeast infections
- Allergic fungal diseases like allergic bronchopulmonary aspergillosis
- Infection limited to the skin only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Mortality (number of deaths per 1000 ICU admissions)
Time frame: six months after the completion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 30769292Chakrabarti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arunaloke Chakrabarti, MD, DNB study director
PGIMER, Chandigarh
Shivaprakash M Rudramurthy, MD principal investigator
PGIMER, Chandigarh
Randeep Guleria, MD principal investigator
All India Institute of Medical Sciences
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoses, run by Fungal Infection Study Forum at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.