| CTRI Number |
CTRI/2022/01/039186 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
30/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
leprosy ulcers and bacterial infections |
|
Scientific Title of Study
|
To evaluate antibiogram and occurrence of bacterial biofilm in leprosy plantar ulcers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Michelle Serene Fernandes |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of dermatology,
Fr Muller Medical College,
Kankanady
Mangalore
Dept of Dermatology,
Fr Muller Road
Kankanady P.O
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09980785447 |
| Fax |
|
| Email |
michelle@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Michelle Serene Fernandes |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology,
Fr Muller Medical college
Kankanady
Mangalore
Dept of Dermatology,
Fr Muller Road
Kankanady P.O
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09980785447 |
| Fax |
|
| Email |
michelle@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Michelle Serene Fernandes |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department Of Dermatology
Fr Muller medical College
Mangalore
Dept of Dermatology,
Fr Muller Road
Kankanady P.O
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09980785447 |
| Fax |
|
| Email |
michelle@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Indian Association of Dematologists, Venereologists and Leprologists (IADVL) research grant |
|
|
Primary Sponsor
|
| Name |
IADVL research grant |
| Address |
Indian Association of Dermatologists, Venereologists and Leprologists,
314-315
3rd Floor KM Trade Tower,
H3, Sector 14, Kaushambi, Ghaziabad,
Uttar Pradesh - 201010 |
| Type of Sponsor |
Research institution |
|
|
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 Michelle Fernandes |
Father Muller Medical College Hospital |
Skin OPD 65,
Fr Muller Medical College Hospital,
Fr Muller Road
Kankanady P.O
Mangalore 575002
Dakshina Kannada
KARNATAKA |
09980785447
michelle@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FatherMuller Institutional Ethics Committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
a) Leprosy patients with plantar ulcers who are not on topical or systemic antibiotics since atleast 2 weeks
b) Age above 18 years |
|
| ExclusionCriteria |
| Details |
a. patients with a history of use of topical or systemic antibiotics within 2 weeks.
b. Patients with ulcer who are admitted in hospital since atleast 5 days which can alter bacterial colonization |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quantitative
measurement of biofilm production by the Microtitre plate method (MTP) will be performed for in clinical isolates of bacteria. An optical
density (OD) greater than 0.240 indicated a strong biofilm producer, an OD
between 0.120–0.240 a moderate biofilm producer and an OD of less than 0.120,
a non-biofilm producer. S. aureus ATCC 25923 will be used as the control
organism for biofilm production
|
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The antimicrobial susceptibility testing (AST) determined by the Kirby-Bauer
disc diffusion method after it is incubated for 18–24 h at 37 °C aerobically, the
isolates will be classified as susceptible, intermediate and resistant as per standard
guidelines. |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
15/01/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sixty-five
leprosy
patients with plantar ulcers attending Dermatology OPD over 24 months period will be
enrolled after obtaining informed consent. Swabs will be collected from Plantar
ulcers. Isolation and identification of bacteria will be performed, based on
culture and standard bacterial identification methods. Antimicrobial
susceptibility testing will be conducted using the disk diffusion test.
Detection of biofilm production will be carried out using the Micro Titre Plate
method (MTP). The pattern of antibiotic resistance exhibited by
biofilm-producers will be compared with non-biofilm-producers. |