A multicentre study to evaluate superficial fungal infections
- Conditions
- Cases are patients with superficial dermatophytosis and controls are healthy volunteers
- Registration Number
- CTRI/2017/07/009032
- Brief Summary
Superficialmycoses are the commonest fungal infections of humans, and mostly caused bykeratinophilic fungi called as dermatophytes. Dermatophytes use keratin as anutrient during skin, hair and nail infections. Based on the formation andmorphology of their conidia, which are the structures of their asexualreproduction, they are classified into three genera, *Trichophyton*, *Microsporum*and *Epidermophyton*. So far, about 30species of dermatophytes have been identified as human pathogens.
Dermatophytesinfect host surfaces containing keratin, including skin, hair, and nails. Bothclimate and lifestyle contribute to the prevalence of dermatophyte infections.Tropical climates and overcrowding predispose population to dermatophyteinfections. Increased urbanization, including the use of occlusive footwear,tight fashioned clothes, community showers and participation in sports, hasalso been linked to higher prevalence.
Dermatophytesare transmitted by direct contact with infected animals and humans or byindirect contact with contaminated fomites. Typical skin lesions ofdermatophytes are annular, erythematous and pruritic patches/plaques which maybe mild or severe depending upon the immunologic status of the host. Dermatophytoses occur as a result of direct invasion of the fungus orhypersensitivity reactions to the microorganism and/ or its metabolic products. It is acommon cutaneous morbidity as a result of severe itching and social impairment.
Over pastfew years, antifungal resistance has emerged due to irrational use of antifungalagents in cutaneous mycoses. Rampant use of corticosteroids containing topicalpolycombinations peculiar to India may be contributing to this fast growingmenance of chronic/recurrent dermatophytosis and “antifungal drug resistanceâ€in tis country particularly. The condition can be treated by local or systemicantifungal therapy depending on the site and severity of the lesions. Somestudies around the world are also noticing resistance to common antifungaldrugs used for the treatment of such dermatophytic infections. Theincidences of relapse and recalcitrant cases are increasing in spite of therapywith complete course of antifungal agents resulting in large pool of recurrentdermatophytoses in the community.
Recurrent dermatophytoses refers to persistentdermatophytoses that run a chronic course with episodes of remission andexacerbation. These patients are potential source of infection not only to their familymembers but also to the public, thus posing a financial and public healthproblem. There are various proposed causes which might contribute tochronicity/recurrence. These include antifungal drug resistance, poor hygiene,intra-familial fungal infections and host factors such as immuno-compromisedstatus, diabetes mellitus, atopy and intake of systemic steroids.The problem of recurrence of superficial dermatophytescauses significant distress to the patients socially, emotionally andfinancially.
Studyform north India showed non-responders to gold standard drug griseofulvin amongthe tinea capitis patients.In 2002,Mukherjee PK et al found *Trichophytonrubrum* strain exhibiting primary resistance to terbinafine. In studyconducted by Sarifakioglu E et al (2007) on 100 isolates of onychomycosis, theyfound terbinafine has lowest minimuminhibitory concenteration (MIC) followed by itraconazole and fluconazole showedgreatest variation in MIC. In astudy conducted by Klafke GB et al (2014) on 100 isolates of onychomycosis theyfound high MIC value for Fluconazole and Itraconazole in 66.7% and 25% of isolates of T.rubrum respectively.[7](file:///C:/Users/adithya/Desktop/Dogra%20sir%20trial/Protocol%20for%20Antifungal%20resistance%20study%20(1).docx#_ENREF_7 "Azambuja, 2014 #12")In one of the study, it was found that recurrent dermatophytoses wasmore frequent in low socioeconomic group and tinea corporis and tinea cruris werefound to be the most clinical forms associated with chronicity.
In this study, we will analyse the prevalence,clinical patterns, pathogens and profile of antifungal susceptibility inpatients suffering from recurrent dermatophytoses
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 300
- Study population 1.All patients above the age of 12 years diagnosed clinically to have recurrent dermatophytoses (excluding nail and scalp infections).
- Control Group: 1.First episode or Only single episode of tinea corporis/cruris/facei in last 12 months The inclusion criteria for centres: 1.There should be an NABL-accredited mycology laboratory equipped for standardized dermatophyte cuture available (the proof of such accreditation must be attached with the application).
- The lab director or the mycologist in-charge must give signed consent in a pre-approved format: 1) agreeing to be a co-investigator for the project, and 2) agreeing to give unimpeded access to the lab for the said purpose (dermatophyte culture) during the full tenure of the project.
- The Investigator must take full responsibility of and provide proof thereof facilities of transportation of biological samples from the site to PGIMER.
- 1.Immunocompromised.
- 2.Pregnancy 3.Lactation.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To estimate the prevalence and clinical patterns of recurrent dermatophytoses 1 year (excluding nail and scalp infections). 1 year
- Secondary Outcome Measures
Name Time Method 1.To evaluate the host and environmental risk factors associated with recurrent dermatophytoses. 2.To study the antifungal susceptibility patterns in these patients.
Trial Locations
- Locations (1)
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER🇮🇳Chandigarh, CHANDIGARH, IndiaDr Suni DograPrincipal investigator9855005941sundogra@hotmail.com