| CTRI Number |
CTRI/2025/04/084712 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of healthy nasal carriers of multi-drug resistant bacteria Staphylococcus aureus |
|
Scientific Title of Study
|
Multi drug resistant staphyloccocus aureus as nasal carriage in healthy individuals of tertiary care center. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Gajanan Nimbalkar |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology 2nd floor in JNMC Building Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021400510 |
| Fax |
|
| Email |
prajaktanimbalkar387@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dhruba Hari Chandi |
| Designation |
Asst Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Microbiology, 2nd floor, JNMC Building Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9584543658 |
| Fax |
|
| Email |
dhrubachandi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prajakta Gajanan Nimbalkar |
| Designation |
Post Graduate ( medical laboratory technology) |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology, 2nd floor, JNMC Building Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021400510 |
| Fax |
|
| Email |
prajaktanimbalkar387@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha,442001,India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Wardha |
| 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 |
| Prajakta Gajanan Nimbalkar |
Jawaharlal Nehru Medical College |
Department of Pathology.2nd floor JNMC Building Sawangi Meghe
Wardha
MAHARASHTRA |
9021400510
prajaktanimbalkar387@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Datta Meghe Institute of Higher Education and Reserch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers will be assessed for presence of staphyloccocus aureus using nasal swabs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All the healthy individuals with age from greater than 15 yrs old and less than 55 yrs old were included
in this study. |
|
| ExclusionCriteria |
| Details |
. Children with the age less than 15 years will be excluded for this study. 2. Old age individuals with age greater than 55 yrs old will be excluded. 3. Any individuals with acute or cronic infection will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will assessed to identify carrier rates and virulence markers of nasal S.aureus.to determine the presence of MDR S.aureus.to detect antimicrobial susceptibility pattern of isolates. |
Assessments will be done at 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
23/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The pathogenicity of Staphylococcus aureus is influenced by two important features: its ability to resist more
than three classes of antibiotics and the capacity to produce several toxins. The worldwide increase in multidrug-resistant bacteria is a worrying phenomenon that is mainly associated with the lack of development of new antibacterial compounds. This increase is linked to the abundant use of antibiotics in humans as well as animals. This multidrug resistance concerns a large variety of microorganisms, both specific and opportunistic pathogens. When these bacteria migrate to usually sterile sites, they can cause different types of infection. This type of evolution from healthy carriage to infection is typical for nosocomial infection. Staphylococcus aureus (including Methicillin-resistant Staphylococcus aureus ) frequently colonizes the human skin and the upper respiratory tract. This study will be a prospective study to assess the drug resistance of staphyloccocus aureus from nasal swabs in healthy individuals. |