| CTRI Number |
CTRI/2024/10/075977 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Skin Fungal Infections: Treatment Challenges and Drug Resistance in Patients from South India |
|
Scientific Title of Study
|
Clinico-mycological factors and in-vitro antifungal drug susceptibility in recalcitrant cutaneous dermatophytoses- a cross-sectional study from south india |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karishma Talamarla Muntimadugu |
| Designation |
Post Graduate |
| Affiliation |
JSS medical college and Hospital |
| Address |
Department of Dermatology, room no. 1014, JSS Hospital, Ramchandra Agrahara, Mysore
Mysore KARNATAKA 570004 India |
| Phone |
9666772929 |
| Fax |
|
| Email |
karishmakarry919@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Ranugha PSS |
| Designation |
Assistant professor,Department of Dermatology |
| Affiliation |
JSS medical college and Hospital |
| Address |
Department of Dermatology, room no. 1014, JSS Hospital, Ramchandra Agrahara, Mysore
Mysore KARNATAKA 570004 India |
| Phone |
9880375157 |
| Fax |
|
| Email |
ranughapss@jssuni.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Karishma Talamarla Muntimadugu |
| Designation |
Post Graduate |
| Affiliation |
JSS medical college and Hospital |
| Address |
Department of dermatology, room no. 1014, JSS Hospital, Ramchandra Agrahara, Mysore
Mysore KARNATAKA 570004 India |
| Phone |
9666772929 |
| Fax |
|
| Email |
karishmakarry919@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS HOSPITAL,Ramachandra Agrahara, MYSORE, Karnataka, INDIA,570004 |
|
|
Primary Sponsor
|
| Name |
KARISHMA TM |
| Address |
JSS HOSPITAL, RAMCHANDRA AGRAHARA, MYSORE,570004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Karishma TM |
JSS HOSPITAL |
Department of Dermatology, JSS Hospital, Ramchandra Agrahara, Mysore, 570004. Mysore KARNATAKA |
9666772929
karishmakarry919@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JSSMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all age groups
Recurrent cases, Relapsing cases, Chronic Dermatophytosis, and Clinically resistant cases of cutaneous dermatophytosis. |
|
| ExclusionCriteria |
| Details |
Isolated dermatophyte infection of the scalp and/ or nails,
Suspected deep dermatophytosis,
dermatophytosis with secondary infection,
Itching without active margins or scaling,
patients who have taken inadequate treatment,
have persistent lesions due to inadequate treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MIC values of dermatophytes to common antifungal drugs in our part of the country shall be obtained.
Higher MIC values or antifungal drug resistance may be found in patients with recalcitrant compared to other previous studies. |
12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prior treatment with antifungal drug may cause increase in the MIC values to that drug in recalcitrant patients.
Trichophyton mentagrophyte may show higher MIC values to antifungal drugs than Trichophyton rubrum
|
12months |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
31/10/2024 |
| 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="6" 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
|
There has been an unprecedented increase in recalcitrant dermatophytosis in India as well as worldwide in the past few years. There are no treatment guidelines for these cases and managing them poses a significant challenge. Despite the widespread prevalence of these infections, there remains a gap in our understanding of the complex interplay between clinical factors, mycological factors, and antifungal drug susceptibility in recalcitrant cases. Antifungal susceptibility studies have been conducted in various regions of India, some have reported resistance to commonly used antifungal drugs while others have found none though they obtained higher MIC values. Also, MIC values are yet to be determined. There is a paucity of published studies from Karnataka detailing the clinico-mycological aspects and drug sensitivity patterns in recalcitrant dermatophytosis. Our study aims to assess the clinical factors, mycological factors, and antifungal drug sensitivity in cases of recalcitrant dermatophytosis. We also intend to compare the clinical and mycological factors as well as prior antifungal treatment details with the minimum inhibitory concentration (MIC) values of the antifungal drugs tested. And we also study the association between antifungal treatment received by the patient and invitro antifungal drug sensitivity . Antifungal drug sensitivity values shall also be compared among different dermatophyte species. |