| 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
|
|
|
Primary Sponsor
|
| Name |
KEM Hospital |
| Address |
Acharya Donde Marg, Parel, Mumbai |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ICU patients, |
|
|
Intervention / Comparator Agent
|
|
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. |