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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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