| 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
|
|
|
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
|
|
|
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.
|