| CTRI Number |
CTRI/2024/04/066326 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mechanism of antibiotic(Fluconazole) resistance for Non- Candida species |
|
Scientific Title of Study
|
Molecular Mechanism of Fluconazole resistance among clinical isolates of Non-albicans candida species in a rural tertiary health care center of central 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 |
Dr Deependra Manish |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology,2nd floor,JNMC building , Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
9199115058 |
| Fax |
|
| Email |
deependramanish@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gargi Mudey |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology 2nd floor JNMC building Sawangi Meghe Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9860265849 |
| Fax |
|
| Email |
gargi.microbiology@dmiher.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Deependra Manish |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology 2nd floor JNMC building Sawangi meghe Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9199115058 |
| Fax |
|
| Email |
deependramanish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi,Wardha,Maharashtra,India-442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Deependra Manish |
Datta Meghe Institute of Higher Education and Research |
Department of Microbiology,Second Floor,JNMC Building,Sawangi,Wardha Wardha MAHARASHTRA |
9199115058
deependramanish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B379||Candidiasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All clinically relevant isolates of Non-albicans candida species that will be isolates from specimens received from February 2024 to August 2026 in the department of microbiology Tertiary health care centre. |
|
| ExclusionCriteria |
| Details |
Samples which shows the growth of Candida albicans will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Isolation of Candida species, Antifungal sensitivity pattern for Azoles among Non-albicans candida species isolates by Disc diffusion method, |
At the end of 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antifungal sensitivity test for fluconazole among Non-albicans candida species by Micro broth dilution method and studying mutations in ERG11 gene. |
At the end of 24 months |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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)
|
22/07/2024 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Numerous patient populations have substantial
clinical relevance for both Candida albicans and the newly discovered
non-albicans Candida spp. Although it is exclusively fungi static against
Candida spp. and there have been reports of both innate and acquired resistance
to fluconazole, the current treatment guidelines list fluconazole as the main
therapeutic choice for the treatment of these infections. There are significant
and unexpected changes between the species, even though many of the resistance
mechanisms seen in C. albicans are also present in the non-albicans species.
The antifungal mechanisms of fluconazole, an azole that is frequently used
to prevent and cure candida infections, are discussed in this review along with
the particular molecular pathways involved in Non-albicans candida species such as C.
parapsilosis, C. tropicalis, C. krusei, and C. glabrata and there resistance
to fluconazole which is crucial for maintaining the effectiveness of one of our
main antifungal medications. This study aims to study the molecular mechanism of Fluconazole
resistance among clinical isolates of Non-albicans Candida species. 78 clinically relevant
isolates of Non-albicans candida
species that will be isolates from specimens received from February 2024 to
August 2026 in the department of microbiology will be studied for fluconazole
resistance using Disc diffusion method and Micro broth dilution method. Further
PCR will be done to explore the molecular mechanism of fluconazole resistance
by studying mutation in ERG11 gene. Results will be drawn from the observations of subjective
and objective parameters. |