| CTRI Number |
CTRI/2025/11/097422 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
mortality benefit of isolating patients infected with multidrug-resistant organisms in ICU |
|
Scientific Title of Study
|
Effectiveness of Isolation of Patients Infected with Multidrug-Resistant Organisms on Mortality in the ICU: A Prospective Cohort Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
pradeep |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of General Medicine, AIIMS Rishikesh, Rishikesh, Dehradun, Uttarakhand, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8870692813 |
| Fax |
|
| Email |
pradeep.med24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Prasan kumar panda |
| Designation |
Additional professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of General Medicine, AIIMS Rishikesh, Rishikesh, Dehradun, Uttarakhand, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9868999488 |
| Fax |
|
| Email |
motherprasanna@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
pradeep |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of General Medicine, AIIMS Rishikesh, Rishikesh, Dehradun, Uttarakhand, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8870692813 |
| Fax |
|
| Email |
pradeep.med24@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand, India, 249203. |
|
|
Primary Sponsor
|
| Name |
pradeep |
| Address |
department of internal medicine, AIIMS rishikesh, Rishikesh, dehradun, uttrakhand, 249203 |
| Type of Sponsor |
Other [] |
|
|
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 PRADEEP P |
AIIMS Rishikesh |
AIIMS Rishikesh, Veerabhadra road, rishikesh, dehradun, Uttarakhand, 249203
Dehradun
UTTARANCHAL |
8870692813
pradeep.med24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults more than or equal to 18 years of age admitted to MICU and Pulmonology ICU.
2. Patients identified with MDR infection at admission or during hospitalization.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mortality of any cause |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
length of ICU stay
3 month risk of readmission or death
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
30/11/2025 |
| 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="4"
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
|
Multidrug-resistant organisms (MDROs) are a major global health threat, causing around 1.3 million deaths in 2019. Antimicrobial resistance (AMR) also imposes heavy economic burdens, with projected healthcare costs of up to USD 1 trillion by 2050. Intensive Care Units (ICUs) have the highest MDRO prevalence due to invasive procedures, patient comorbidities, and frequent antibiotic use. While patient isolation is recommended to prevent MDRO transmission, its effect on outcomes such as mortality remains debated—some studies report reduced infection spread, whereas others highlight delayed care and psychological distress. This prospective cohort study will assess the impact of MDRO-infected patient isolation on mortality in ICU to guide balanced infection control policies. |