| CTRI Number |
CTRI/2026/02/102987 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding skin infections in pemphigus patients and the best medicines to treat them |
|
Scientific Title of Study
|
Profile of cutaneous bacterial infection and antibiotic sensitivity pattern in patients with pemphigus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranay Raj |
| Designation |
Postgraduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 714, 7th floor, Dermatology department, OPD building, Lok Nayak Hospital
Central DELHI 110002 India |
| Phone |
8603766954 |
| Fax |
|
| Email |
rajpranay41@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K D Barman |
| Designation |
Director Professor and HOD |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Dermatology,STD and Leprosy, Maulana Azad Medical College and Associated Lok Nayak Hospital
Central DELHI 110002 India |
| Phone |
9868961716 |
| Fax |
|
| Email |
kdebbarman@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K D Barman |
| Designation |
Director Professor and HOD |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Dermatology,STD and Leprosy, Maulana Azad Medical College and Associated Lok Nayak Hospital
DELHI 110002 India |
| Phone |
9868961716 |
| Fax |
|
| Email |
kdebbarman@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru Marg, Maulana Azad Medical College Campus, Delhi Gate, New Delhi, Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2-Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government 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 Pranay Raj |
Lok Nayak Hospital |
Ward 22/23, Skin Ward, Maulana Azad Medical college campus, 2-Bahadur Shah Zafar Marg, New Delhi - 110002 Central DELHI |
8603766954
rajpranay41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.I.P.M.E.R, Guru Nanak Eye Centre, New Delhi- 110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L10||Pemphigus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically/ histologically proven cases of pemphigus having active skin/mucosal lesions of all age groups will be recruited for the study.
2. Patients who provide informed written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who have taken systemic or topical antibiotics within the past 2 weeks.
2. Patients with chronic skin conditions like psoriasis or atopic dermatitis, which could affect bacterial colonization.
3. Patients who refuse to participate or do not provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the profile of cutaneous bacteria isolated from the eroded lesions of pemphigus patients. |
At Baseline and At 10th day of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•
To determine antibiotic sensitivity pattern of bacterial agent isolated from skin erosions.
•
To find correlation between bacterial growth in skin swab culture & blood culture. |
At Baseline & At 10th day of admission |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
14/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background of the Study
Pemphigus is a rare autoimmune blistering disorder characterized by fragile skin and mucosal erosions due to loss of epidermal integrity. This disruption of the skin barrier, combined with prolonged hospitalization and use of systemic immunosuppressive therapy, makes patients highly susceptible to secondary cutaneous bacterial infections. Such infections significantly increase morbidity and are among the leading causes of mortality in pemphigus patients.
Common bacterial pathogens implicated include Staphylococcus aureus, Pseudomonas aeruginosa, and other opportunistic organisms. In recent years, the emergence of antibiotic-resistant strains, including methicillin-resistant Staphylococcus aureus (MRSA), has further complicated infection management. Empirical and indiscriminate use of broad-spectrum antibiotics may worsen antimicrobial resistance and adversely affect patient outcomes.
Despite the clinical importance of infections in pemphigus, there is limited region-specific data from India regarding the bacteriological profile of cutaneous infections and their antibiotic sensitivity patterns. A better understanding of local microbial flora and resistance trends is essential for guiding rational, targeted antimicrobial therapy.
Purpose of the Trial
The purpose of this study is to identify the bacterial organisms responsible for secondary skin infections in patients with pemphigus and to determine their antibiotic sensitivity patterns. By correlating culture results from skin lesions with blood cultures, the study aims to provide microbiological evidence that can support appropriate antibiotic selection, reduce unnecessary empirical antibiotic use, and promote antibiotic stewardship.
The findings of this study are expected to help clinicians optimize infection management strategies in pemphigus, thereby reducing complications, improving clinical outcomes, and contributing to region-specific antimicrobial surveillance data. |