FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013733 [Registered on: 07/05/2018] Trial Registered Retrospectively
Last Modified On: 14/05/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study to desribe usage of antifungal drugs in Selected Clinical Care Settings of a Tertiary Care Teaching Hospital 
Scientific Title of Study   Antifungal Drug Utilization in Selected Clinical Care Settings of a Tertiary Care Teaching Hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirmala Rege 
Designation  Professor and Head  
Affiliation  KEM Hospital 
Address  Department of Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital, Acharya Donde Marg, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9820444940  
Fax    
Email  nimarege@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kruttika Chitnis 
Designation  Junior Resident, 2nd year 
Affiliation  KEM Hospital 
Address  Seth GS Medical College & KEM Hospital, Acharya Donde Marg, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  7506829728  
Fax    
Email  krchitnis@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kruttika Chitnis 
Designation  Junior Resident, 2nd year 
Affiliation  KEM Hospital 
Address  Seth GS Medical College & KEM Hospital, Acharya Donde Marg, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  7506829728  
Fax    
Email  krchitnis@yahoo.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  KEM Hospital 
Address  Acharya Donde Marg, Parel, Mumbai 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirmala Rege  Seth GSMC & KEMH  MICU, PICU and Hematology ward Seth GSMC & KEMH
Mumbai
MAHARASHTRA 
9820444940

nimarege@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Seth GSMC and KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ICU patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  28.00 Day(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients admitted in either MICU, PICU or in Hematology ward and receiving antifungal drugs as a part of his/her treatment.
2. Patients or LAR willing to give informed consent 
 
ExclusionCriteria 
Details  1. Re-consent refusal from patient, after regaining consciousness when admitted in unconscious state
2. Patients receiving prophylactic antifungal therapy 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
a. extent of use of antifungal drugs Prescribed Daily Doses (PDDs) & Duration Of Therapy (DOTs)
b. Appropriateness of antifungal use 
a. extent of use of antifungal drugs Prescribed Daily Doses (PDDs) & Duration Of Therapy (DOTs)
b. Appropriateness of antifungal use 
 
Secondary Outcome  
Outcome  TimePoints 
a. Total number of adverse events occurring in patients receiving antifungal drugs
d. Percentage of adverse reactions causally related to AFAs: according to WHO-UMC or Naranjo algorithm
c. Severity of ADRs as per modified Hartwig-Siegel scale
d. Percentage of ADRs which are preventable, according to Schumock and Thornton scale
 
first visit: Day 0
subsequent visits: daily till participant is discharged
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/06/2017 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   study not yet completed 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Documentation and analysis of use of antifungal therapy and its related adverse events (AE)/adverse drug reactions (ADRs) mainly aims at promotion of rational and safe use of antifungal agents for invasive fungal infections. Considering the complexity of diagnosis, high costs of therapy and high morbidity and mortality associated with systemic fungal infections, antifungal therapy should follow clearly defined guidelines.

Systemic antifungal treatments are very expensive, and are generally prescribed for a long duration. Routine and/or irrational use of drug regimens may expose a substantial portion of these patients to problems such as treatment failure, drug interactions and high risk of adverse events. In terms of successful therapy, current antifungal efficacy is limited by late diagnosis, limited diagnostic facilities, inadequate efficacy for many infections, adverse events and increasing rates of acquired resistance.

 A careful antifungal stewardship programme in a tertiary care teaching hospital is essential to monitor these therapies in terms of extent and appropriateness of prescription, and to rationalize the use of these highly expensive drugs. So, the current prospective observational study will highlight the extent of use, adverse events, resistance pattern & eventually the overall prescription pattern of antifungal agents (AFAs) in selected clinical care setup such as MICU, PICU & Haematology ward.

This study will attempt to include about 100 patients admitted in Medical Intensive Care Unit (MICU)/Pediatric Intensive Care Unit (PICU)/Haematology ward & receiving Antifungal Therapy as a part of their treatment, over a period of 15 months. After approval from IEC and obtaining written ICD from the patients and/or LAR, data will be collected, and noted down in CRF. Evaluation of use will be on the basis of extent i.e. incidence of use as well as appropriateness. AE/ADR(s), if any, occurring in these patients will be recorded as per Central Drug Control Standard Organization (CDSCO) norms and later analyzed using WHO-UMC scale, Naranjo algorithm, modified Hartwig-Siegel scale, Schumock and Thornton scale.

 

 
Close