FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
Close