| CTRI Number |
CTRI/2014/11/005219 [Registered on: 25/11/2014] Trial Registered Prospectively |
| Last Modified On: |
21/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of antifungal drug susceptibility in fungal infections of the skin |
|
Scientific Title of Study
|
A study of in-vitro drug susceptibilty patterns of dermatophytes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shital Poojary |
| Designation |
Professor and Head |
| Affiliation |
Department of Dermatology, K.J.Somaiya Medical College |
| Address |
Department Of Dermatology, K.J.Somaiya Medical College,Everard Nagar, Sion-Chunnabhatti, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9820601511 |
| Fax |
24091855 |
| Email |
spoojary2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Poojary |
| Designation |
Professor and Head |
| Affiliation |
Department of Dermatology, K.J.Somaiya Medical College |
| Address |
Department Of Dermatology, K.J.Somaiya Medical College,Everard Nagar, Sion-Chunnabhatti, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9820601511 |
| Fax |
24091855 |
| Email |
spoojary2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jimish Bagadia |
| Designation |
Senior Resident |
| Affiliation |
Department of Dermatology, K.J.Somaiya Medical College, |
| Address |
Department Of Dermatology, K.J.Somaiya Medical College,Everard Nagar, Sion-Chunnabhatti, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9702713534 |
| Fax |
|
| Email |
jimishb@gmail.com |
|
|
Source of Monetary or Material Support
|
| IADVL-Ranbaxy research grant |
|
|
Primary Sponsor
|
| Name |
IADVL |
| Address |
C/O Honorary General Secretary
Dr Rashmi Sarkar,
Hony. General Secretary IADVL,
Dept of Dermatology and Venereology,
Ward No-22/23 (Through Gate No.3),
Maulana Azad Medical College and Lok Nayak Hospital,
Bahadur Shah Zafar Marg,
New Delhi-110002
|
| Type of Sponsor |
Other [IADVL Research grant] |
|
|
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 Shital Poojary |
Department of Dermatology, K.J.Somaiya Medical College |
Everard Nagar, Sion-Chunnabhatti, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA |
9820601511
spoojary2004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of K.J.Somaiya Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Superficial dermatophyte infections of the skin, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients clinically diagnosed to be suffering from superficial dermatophytosis |
|
| ExclusionCriteria |
| Details |
1. Clinical evidence of superadded bacterial infection
2. Patients not consenting to provide a sample |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identifying the causative agents responsible for dermatophyte infections in Mumbai, India
2. To determine the minimum inhibitory concentration values( MIC 50 & MIC 80 ) OF THE FOLLOWING DRUGS : Terbinafine, Griseofulvin, Fluconazole, Itraconazole, Ketoconazole, Clotrimazole and Sertaconazole against these dermatophytes |
One Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To select the best antifungal drug for a patient of Dermatophytosis. thereby reducing the disease morbidity |
1year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/12/2014 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An increasing trend of patients not responding to conventional oral as well as topical antifungal medications is seen recently all over the world due to indiscriminate use of antifungals.
It is of utmost importance to assess whether this clinical non-responsiveness of dermatophyte infections is due to resistance to the drugs or due to various other factors such as compliance, dosage, drug interactions, other co-morbid conditions or altered pharmacokinetics. This will ultimately help to reduce the morbidity levels of what is believed to be an easily curable disease.
80 patients clinically diagnosed to be having superficial dermatophytosis will be included in the study after ruling out superadded bacterial infections
Specimen collection will be done from different sites ( skin, nails, hair) depending on site of involvement in the dermatology OPD. The specimen will be subjected to fungal culture followed by species identification and drug susceptibilty testing against the following drugs: Terbinafine, griseofulvin , fluconazole, itraconazole, ketoconazole, clotrimazole and sertaconazole using broth microdilution method( CLSI M38-A) |