| CTRI Number |
CTRI/2024/12/078082 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
study of Risk factors linked to infections in neurologically ill patients caused by strong antibiotic resistant bacteria |
|
Scientific Title of Study
|
Risk factors associated with carbapenem-resistant enterobacterales infection in neuro-critical care 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 |
Indrajit Vithalrao Suryavanshi |
| Designation |
Senior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Room No. 213, second floor Department of Critical Care Medicine, Bharati Hospital and Research Centre, Satara-Road, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9923803839 |
| Fax |
|
| Email |
suryaindra007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishwanath Patil |
| Designation |
Professor |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Room no. 213, Second Floor, Department of Critical Care Medicine, Bharati Hospital and Research Centre, Pune-Satara Road, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9923803839 |
| Fax |
|
| Email |
vishwanath629@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Indrajit Vithalrao Suryavanshi |
| Designation |
Senior Resident |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Room No. 213, second floor, Department Of Critical Care Medicine, Bharati Hospital And Research Centre, Pune-Satara Road, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9923803839 |
| Fax |
|
| Email |
suryaindra007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Pune-Satara road, Pune-411043, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| 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 Indrajit Vithalrao Suryavanshi |
Bharati Hospital and Research Centre, Pune |
Room no 213, second floor, Department of Critical Care Medicine Bharati Hospital and Research Centre, Pune-Satara Road, Pune 411043, Maharashtra, India.
Pune
MAHARASHTRA |
9923803839
suryaindra007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All neurocritical care patients with suspected sepsis for whom culture has been sent
2. 18 years of age or older |
|
| ExclusionCriteria |
| Details |
1. Neurocritical care patients with pre-existing Carbapenem resistant enterobacteral infection
2. Patients other than neurological disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the risk factors of carbapenem-resistant enterobacterales infection in neuro-critical care patients |
14-28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
20/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The wide dissemination of carbapenem-resistant Enterobacteriaceae (CRE) has been linked with the high morbidity and mortality rates among patients with acute concurrent illnesses, particularly intensive care unit patients. However, the relationship between CRE infection and risk factors in patients managed in ICUs is not fully elucidated. Neurocritical care patients are vulnerable because of low GCS, prolonged ICU stay, prolonged use of multiple invasive catheters Therefore we decided to study the risk factors for carbapenem resistant enterobacterals in neurocritical patients. Neuro critically ill patients includes acute intracranial injury (e.g., traumatic brain injury, hemorrhagic stroke), or ischemic stroke, neuromascular weakness and spinal cord injury. All neurocritical care patients who are 18 years of age or older with suspected sepsis for whom culture has been sent are included in study and the patient with CRE culture positive will be the case and non-CRE including no growth will be control. data will be filled in excel sheet and analysed. |