| CTRI Number |
CTRI/2019/02/017657 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
DRUG RESISTANCE IN FUNGAL SKIN INFECTIONS |
|
Scientific Title of Study
|
ELUCIDATING THE DERMATOPHYTE SPECTRUM THROUGH RAPID MULTIPLEX PCR AND DETECTION OF ANTIFUNGAL DRUG RESISTANCE CAUSED BY MUTATIONS IN SQUALENE EPOXIDASE AND 14-ALFA DEMETHYLASE GENE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyothi Jayaraman |
| Designation |
Senior Resident |
| Affiliation |
Father Muller medical college |
| Address |
Department of dermatology, Father Muller medical college hospital, kankanady, Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8861631648 |
| Fax |
|
| Email |
derm.jyo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghashree G |
| Designation |
PG Resident |
| Affiliation |
Father Muller medical college |
| Address |
Department of dermatology, Father Muller medical college hospital, kankanady, Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9741639736 |
| Fax |
|
| Email |
megha91leo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghashree G |
| Designation |
PG Resident |
| Affiliation |
Father Muller medical college |
| Address |
Department of dermatology, Father Muller medical college hospital, kankanady, Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9741639736 |
| Fax |
|
| Email |
megha91leo@gmail.com |
|
|
Source of Monetary or Material Support
|
| IADVL (Indian association of dermatology venerology and leprology) research grant 2018
IADVL headquarters, 4772-73 pvt no., T-3 & T-4, 3rd floor, 23 bharat ram road, darya ganj, new delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
IADVL |
| Address |
Dr. Umashankar Nagaraju
Honorary Secretary General
Indian Association of Dermatologists Venereologists & Leprologists
IADVL National Headquarters
4772-73 Pvt No.T-3 & T-4 3rd Floor
23 Bharat Ram Road Darya Ganj
New Delhi-110002. |
| Type of Sponsor |
Other [INDIAN ASSOCIATION OF DERMATOLOGIST VENEROLOGIST AND LEPROLOGIST] |
|
|
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 meghashree g |
father muller medical college |
Department of dermatology, room no 65, Father Muller medical college hospital,kankanady,mangalore,575002
Dakshina Kannada
KARNATAKA |
9741639736
megha91leo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller medical college institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All the patients above 18 years of age with suspected dermatophytic skin infection willing to give consent will be included in the study |
|
| ExclusionCriteria |
| Details |
below 18 years
those unwilling to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of species of dermatopytes and drug resistance in dermatophytic skin infection by rapid methods1 |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
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)
|
01/03/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
References
1. Surendran K, Bhat RM, Boloor R, Nandakishore B, Sukumar D. 2014. A clinical and mycological study of dermatophytic infections. Indian J Dermatol . 59:262-7.
2.Dogra S, Uprety S. 2016. The menace of chronic and recurrent dermatophytosis in India: Is the problem deeper than we perceive? Indian Dermatol Online J 7:73-6.
3. Gupta AK, Kohli Y. 2003. Evaluation of in vitro resistance in patients with
onychomycosis who fail antifungal therapy. Dermatology 207:375–380.
4. Mukherjee PK, Leidich SD, Isham N, Leitner I, Ryder NS, Ghannoum MA. 2003. Clinical Trichophyton rubrum strain exhibiting primary resistance to terbinafine. Antimicrob Agents Chemother 47:82–6.
5.Osborne CS, Leitner I, Favre B, Neil S, Ryder NS. 2005. Amino Acid Substitution in Trichophyton rubrum Squalene Epoxidase Associated with Resistance to Terbinafine. Antimicrob Agents Chemother 49:2840–4.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
All clinically identified cases of dermatophyte skin infections not on treatment with topical and/or systemic antifungal from 2 weeks prior will be included in the study. Skin scrapings will be collected using no.15 sterile blade on the Dermatophyte Test Media and KOH mount will be done. The media that shows growth of filamentous fungi will be then subcultured on to SDA for species identification. A portion of the skin scrapings (~100 mg) will be aliquoted for DNA extraction. Fungal DNA will be extracted from the skin scraping . The extracted DNA will be quantified using a Nanodrop UV spectrophotometer. Conventional PCR and Species specific RT PCR will be performed . It is performed for live fungi where protein synthesis is taking place. PCR products will be resolved by horizontal gel electrophoresis and results will be analyzed using the gel documentation system. The amplicons will be purified and then sequenced. Sequences will be analyzed using bioinformatics tools to identify species and determine the clonal nature of the fungi detected. Squalene epoxidase gene will be amplified using three sets of primers. The sequences will then be analyzed for point mutations using bioinformatics tools. Primers for CYP51 gene which codes for 14α-demethylase will be designed. Cycling conditions will be optimized.This target gene will be amplified and sequenced. The sequences will then be analyzed for mutations using bioinformatics tools. |