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CTRI Number  CTRI/2025/07/090010 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The Silent Threat Drug-Resistant Infections Among ICU Cancer Patients 
Scientific Title of Study   Evaluating the Incidence Clinical Outcomes and impact of Multi Drug Resistant Infections Among critically ill Cancer Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijeta Bajpai Batra 
Designation  Associate Professor 
Affiliation  HBCH and Mahamana Pandit Madan Mohan Malviya Cancer Centre (Tata Memorial Centre), Varanasi 
Address  Department of Microbiology,3rd Floor MPMMCC,Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9902623877  
Fax    
Email  Vijetabajpaikgmu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vijeta Bajpai Batra 
Designation  Associate Professor 
Affiliation  HBCH and Mahamana Pandit Madan Mohan Malviya Cancer Centre (Tata Memorial Centre), Varanasi 
Address  Department of Microbiology,3rd Floor MPMMCC,Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9902623877  
Fax    
Email  Vijetabajpaikgmu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vijeta Bajpai Batra 
Designation  Associate Professor 
Affiliation  HBCH and Mahamana Pandit Madan Mohan Malviya Cancer Centre (Tata Memorial Centre), Varanasi 
Address  Department of Microbiology,3rd Floor MPMMCC,Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9902623877  
Fax    
Email  Vijetabajpaikgmu@gmail.com  
 
Source of Monetary or Material Support  
Tata Research and Administrative Council Mahamana Padit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital (Tata Memorial Unit) Varanasi UP 221005 
 
Primary Sponsor  
Name  Siddarth K C 
Address  Mahamana Padit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital (Tata Memorial Unit) Varanasi UP 221005 
Type of Sponsor  Other [Self] 
 
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 
Vijeta Bajpai Batra  Mahamana Padit Madan Mohan Malviya Cancer Centre   Department of Microbiology 3rd floor Mahamana Padit Madan Mohan Malviya Cancer Centre
Varanasi
UTTAR PRADESH 
9902623877

vijetabajpaikgmu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (3) ICD-10 Condition: C321||Malignant neoplasm of supraglottis, (4) ICD-10 Condition: B956||Staphylococcus aureus as the causeof diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Adult more than 18 years
2 Admitted in ICU or HDU
3 Diagnosed with Cancer
4 Whose Sample is sent for culture in microbiology Lab
5 Labortaory Confirmed, recognized pathogen and opportunistic commensal  
 
ExclusionCriteria 
Details  1 Pregnant individual and paediatric patient
2 Laboratory culture conatmination
3 who are not willing to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of Multi Drug Resistant infection in crtically ill patient admitted in ICU and HDU in tertiary oncology Centre  8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1 To determine the incidence of Multi Drug Resistant Hospital acquired infection in crtically ill patient admitted in ICU
2 To identify associated risk factors in MDR infection
3 Comparision of mortality rates hospital stay duration & complications
 
8 Weeks 
 
Target Sample Size   Total Sample Size="232"
Sample Size from India="232" 
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)   03/08/2025 
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="1"
Months="6"
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  

Cancer patients admitted to Intensive Care Units (ICUs) and High Dependency Units (HDUs) are at heightened risk of multi-drug resistant (MDR) infections due to immunosuppression from chemotherapy prolonged hospital stays, invasive procedures, and frequent antibiotic exposure.   emergence of multi-drug resistant (MDR) (1) pathogens—defined as microorganism’s resistant to at least one agent in three or more antimicrobial categories.   (2) The rise of MDR pathogens, including carbapenem-resistant Enterobacteriaceae (CRE), extended-spectrum beta-lactamase(ESBL) producers, methicillin-resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii, poses a significant challenge in oncology critical care. These infections lead to higher mortality, prolonged ICU stays, increased healthcare costs, and delays in cancer treatment, necessitating urgent epidemiological and clinical investigations.

Studies report 20–40% prevalence of MDR bacterial infections in hospitalized cancer patients, with higher rates in hematologic malignancies (e.g., leukemia, lymphoma) due to prolonged neutropenia.  Prevalence increases to 40–60% due to invasive devices (ventilators, catheters) and broad-spectrum antibiotic use. Healthcare-associated infections (HAIs) are a leading cause of morbidity and mortality globally, contributing to an estimated 7 lakhs (700,000) deaths annually, with vulnerable populations such as cancer patients disproportionately affected. MDR Acinetobacter and CRE are dominant in ICUs, with mortality rates exceeding 50–70%. In Oncology ICU Higher incidence due to immunosuppression: 20–50 MDR infections per 1,000 ICU days. Carbapenem-resistant Enterobacteriaceae (CRE) incidence is 2–5 times higher in cancer ICUs vs. general ICUs. This study aims to determine the incidence of MDR infections in critically ill cancer patients, identify risk factors, and compare clinical outcomes (mortality, ICU stay, complications) between MDR and non-MDR groups. Findings will guide infection control policies, antibiotic stewardship programs, and empirical treatment protocols in oncology ICUs.

 

 
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