FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069514 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A descriptive study regarding use of antifungal agents in critically ill patients 
Scientific Title of Study   Prescribing Practices of Antifungal Therapy in a Mixed Icu- a Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASHIQUE ALI N K 
Designation  DM Post Graduate Student 
Affiliation  St. Johns medical college Bangalore 
Address  Department of critical care medicine St. Johns medical college Bangalore- India

Bangalore
KARNATAKA
560034
India 
Phone  7907503747  
Fax    
Email  ashiqueali.nk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DIPALI ANAND TAGGARSI 
Designation  Assistant Professor  
Affiliation  St. Johns medical college Bangalore 
Address  Department of critical care medicine St. Johns medical college Bangalore- India

Bangalore
KARNATAKA
560034
India 
Phone  9902586487  
Fax    
Email  dipali.tagg@gmail.com  
 
Details of Contact Person
Public Query  
Name  ASHIQUE ALI N K 
Designation  DM Post Graduate Student 
Affiliation  St. Johns medical college Bangalore 
Address  Department of critical care medicine St. Johns medical college Bangalore- India

Bangalore
KARNATAKA
560034
India 
Phone  7907503747  
Fax    
Email  ashiqueali.nk@gmail.com  
 
Source of Monetary or Material Support  
Department of critical care medicine St. Johns medical college Bangalore-560034 
 
Primary Sponsor  
Name  ASHIQUE ALI N K 
Address  DM Post Graduate Student Department of critical care medicine St. Johns medical college Bangalore- India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ASHIQUE ALI N K  St. Johns medical college Bangalore  Department of critical care medicine Medical Intensive Care Unit
Bangalore
KARNATAKA 		 7907503747

ashiqueali.nk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St Johns Medical College Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B449||Aspergillosis, unspecified, (2) ICD-10 Condition: B49||Unspecified mycosis, (3) ICD-10 Condition: B409||Blastomycosis, unspecified, (4) ICD-10 Condition: B419||Paracoccidioidomycosis, unspecified, (5) ICD-10 Condition: B439||Chromomycosis, unspecified, (6) ICD-10 Condition: B371||Pulmonary candidiasis, (7) ICD-10 Condition: B375||Candidal meningitis, (8) ICD-10 Condition: B376||Candidal endocarditis, (9) ICD-10 Condition: B377||Candidal sepsis, (10) ICD-10 Condition: B379||Candidiasis, unspecified, (11) ICD-10 Condition: B459||Cryptococcosis, unspecified, (12) ICD-10 Condition: B440||Invasive pulmonary aspergillosis, (13) ICD-10 Condition: B441||Other pulmonary aspergillosis, (14) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (15) ICD-10 Condition: B448||Other forms of aspergillosis, (16) ICD-10 Condition: B448||Other forms of aspergillosis, (17) ICD-10 Condition: B440||Invasive pulmonary aspergillosis, (18) ICD-10 Condition: B378||Candidiasis of other sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted in St John’s Medical College Hospital ICU fulfilling the criteria during the study period will be eligible for inclusion
1. Patient admitted in the ICU, already started on systemic antifungal therapy.
2. Patients above 18years of age
3. Both medical and surgical patients.
 
 
ExclusionCriteria 
Details  1. Patients below 18 years of age.
2. Nonconsenting patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
factors influencing initiation of antifungals in ICU  ICU admission days when antifungal therapy was started
 
 
Secondary Outcome  
Outcome  TimePoints 
ICU length of stay

Hospital mortality

28-day mortality
 		 ICU admission days

Hospital days after discharging from the ICU

28th day 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   As per the  recent trend fungal infections in ICU are becoming increasingly common. This is complicated by high mortality, especially in invasive fungal infections. Early diagnosis and initiation of antifungals is the standard of care which is limited by limitation in rapid diagnostic tests. Hence empiric and pre-emptive antifungal treatment are common and are the prescribing practices along with definitive therapy which usually delays the initiation of treatment. There is a recent emergence of resistant fungal infections among ICU patients, and we have limited number of antifungal agents which can be useful in ICU population. They are also very expensive. Bacterial and fungal infections in ICU share similar clinical picture which further complicates and delay the diagnosis. This study aimes to study the factors influencing initiation and choice of antifungal therapy in critically ill patients based on clinical profile, biomarkers and culture or histopathological data. primary objectives was to To identify the factors leading to initiation of antifungal therapy in ICU including patient’s clinical profile, biomarkers and histopathology or cultures. The secondary objectives would be To study the pattern of antifungal prescription in ICU, To evaluate the types of fungal infection in ICU and diagnostic modalities being used and Outcomes of patients with fungal infections in ICU (ICU length of stay,  hospital mortality and     28-day mortality). Methodology of study will be those patients admitted in St John’s Medical College Hospital ICU who are eligible based on the inclusion and exclusion criteria will be enrolled in the study.  All patients initiated on antifungal therapy in ICU will be recruited. Reason for initiation of antifungals will be collected based on proforma. Clinical profile will be recorded, APACHE II score will be calculated, Commonly associated comorbidities (Charlson comorbidity index) will be entered. Relevant data for diagnosing fungal infection will be collect from patient records  including Specimen microscopic examination for fungal elements, biomarkers – galactomannan (GM), β-D glucan, appropriate Imaging leading to diagnosis of fungal infection – (eg:CT thorax), PCR test (eg: Biofire panel, meningoencephalitis panel etc), fungal cultures (body fluids/tissue), is to pathology from tissues or Source/sources of fungus isolated will be collected. Antifungals used and duration of treatment along with Outcomes of patients with fungal infections in ICU aslo will be collected. 
Close