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CTRI Number  CTRI/2024/11/077374 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On: 30/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   Impact of Penicillin and Other Antibiotic Allergy Labels on Antimicrobial Resistance 
Scientific Title of Study   The Burden of Penicillin and other Antibiotic Allergy Labels and Antimicrobial Resistance in Low and Middle-Income Countries (PALAR study) 
Trial Acronym  PALAR  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devasahayam J Christopher 
Designation  Sr. Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Pulmonary Medicine (Ranipet Campus)
Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU
632517
India 
Phone  09443306573  
Fax    
Email  djchris@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Devasahayam J Christopher 
Designation  Sr. Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Pulmonary Medicine (Ranipet Campus)
Christian Medical College, Vellore (Ranipet Campus)

TAMIL NADU
632517
India 
Phone  09443306573  
Fax    
Email  djchris@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Devasahayam J Christopher 
Designation  Sr. Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Pulmonary Medicine (Ranipet Campus)
Christian Medical College, Vellore (Ranipet Campus)

TAMIL NADU
632517
India 
Phone  09443306573  
Fax    
Email  djchris@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
UK R and I Global Challenges Research Fund via Institute of Global Innovation 
 
Primary Sponsor  
Name  UK R and I Global Challenges Research Fund via Institute of Global Innovation 
Address  University of Birmingham United Kingdon 
Type of Sponsor  Government funding agency 
 
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 DJ Christopher  Christian Medical College  Department of Pulmonary Medicine Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU 		 09443306573

djchris@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Office of Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  AAL Arm-Work Package 1

Adult patients (≥18 years) attending the OPD or are admitted to medical wards

AMC Arm -Work package 2:

Adult patients (≥18 years) admitted in target wards or attending outpatient department(might vary between sites) with a microbiologically diagnosed bacterial infection.
 
 
ExclusionCriteria 
Details  AAL Arm-Work Package 1 and 2

Unable to or lacks capacity to give informed Consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The burden of antibiotic allergy on the Indian healthcare system and its direct relation with antimicrobial resistance can be established.

There are no studies on this topic done in India yet
 		 Baseline, end of 1 week and 3 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="8200"
Sample Size from India="8200" 
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)   06/01/2025 
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  

Background:

Antimicrobial resistance (AMR) is a major global public health problem claiming an estimated 700,000 lives/year. Multiple factors contribute to AMR and research in High Income Countries (HICs) has shown that antibiotic allergy labels (AALs), specifically penicillin allergy labels (PALs) significantly enhance the risk of AMR. Such information is not available for low-middle income countries(LMIC).

 Methods:

This is an Observational study done in 4 Low to middle income countries, India, Sri Lanka, Indonesia and Egypt. A target area will be identified for the AMR arm and the AAL arm of the study at each institution.  

The following drug-bug combinations from the WHO Global AMR Surveillance System (GLASS) manual will be followed for AMR surveillance:

•          Escherichia coli vs.  3rd generation cephalosporins and fluoroquinolones

•          Klebsiella pneumoniae vs. 3rd generation cephalosporins and carbapenems

•          Staphylococcus aureus vs. oxacillin or cefoxitin

•          Streptococcus pneumoniae vs. penicillin or oxacillin

•          Salmonella species vs. fluoroquinolones

•          Shigella species vs. fluoroquinolones

•          Neisseria gonorrhoeae vs. 3rd generation cephalosporins

 

Antimicrobial susceptibility testing for priority pathogens will be carried out in line with international standards. The status of the isolates with regard to whether isolates are susceptible, intermediate or resistant (S/I/R) according to clinical breakpoints defined by EUCAST or CLSI. Zone sizes (mm) will also be measured and recorded. At the extended and advanced levels, minimum inhibitory concentrations (MICs) will be determined, e.g., by micro broth dilution (manual or automated) or gradient diffusion tests such as E-Tests. MIC values will be recorded (in case breakpoints change in the future).

 

In order to assess the impact of AALs on the development of AMR, we will analyze patients presenting with both invasive and non-invasive infections with Staphylococcus aureus, enterococcal species, extended-spectrum beta-lactamase (ESBL) producing Enterobacterales and carbapenem-resistant organisms. Data will be collected in bacterial sets, using age and sex-matched controls both for invasive and non-invasive infection based upon the following combinations:

 

•          Staphylococcus aureus vs methicillin-resistant Staphylococcus aureus

•          vancomycin-sensitive enterococci vs vancomycin-resistant enterococci

•          ESBL-nonproducing vs ESBL producing Enterobacterales

•          Carbapenem-sensitive vs Carbapenem-resistant organisms (genus and species of the organism to be matched).

Informed consent would be obtained and the data will be captured on a standard study.

 

 Results:

Prevalence of AALs will be calculated at each site and across all sites. Descriptive statistics will be generated as per study aims and objectives. A descriptive analysis will be carried out to report frequency distribution as per WHO AWaRe classification.  Incidence rates of AMR will be reported (overall and for individual bacteria as stated above) for invasive and non-invasive infections.  

 


 
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