| CTRI Number |
CTRI/2024/09/073400 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
In Vitro Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Detection of bacterial and fungal infection by RT PCR Kits in suspected sepsis patients. |
|
Scientific Title of Study
|
A prospective, observational, and multi-centric study to evaluate the performance and clinical utility of GeNei Sepsis Kit composed of Bacterial and Fungal Pathogen Detection panels and Antimicrobial
Resistance Detection Kit, in comparison to conventional Blood Culture method in patients suspected of sepsis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-GEN-SEP-2024 Version 1.0 dated 31-May-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Plot No.5, Unit No. 325,City Centre Mall, Sector 12 Dwarka, New Delhi
South West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Plot No.5, Unit No. 325,City Centre Mall, Sector 12 Dwarka, New Delhi
South West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Seshadri |
| Designation |
CEO |
| Affiliation |
Genei Laboratories Pvt. Ltd |
| Address |
No.6, 6th Main, College Road,Near SRS Road,Peenya
Bangalore
KARNATAKA
560097
India |
| Phone |
9819141760 |
| Fax |
|
| Email |
rohit.seshadri@geneilabs.com |
|
|
Source of Monetary or Material Support
|
| Genei Laboratories Pvt. Ltd.
No.6, 6th Main, College Road, Near SRS Road, Peenya, Bengaluru, Karnataka 560097, India |
|
|
Primary Sponsor
|
| Name |
Genei Laboratories Pvt. Ltd. |
| Address |
No.6, 6th Main, College Road,Near SRS Road, Peenya, Bengaluru, Karnataka 560097, India |
| Type of Sponsor |
Other [In Vitro Diagnostic Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anup R warrier |
Aster Medcity |
Department of Infectious Disease, OPD in Tower 1, Main Building, Ground Floor, Kuttisahib Road, Near Kothad Bridge, South Chittoor P.O, Cheranelloor, Kochi, Kerala-682027
Ernakulam
KERALA |
9745012477
dranup.warrier@asterdmhealthcare.com |
| Dr Ruchi Shetty |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Department of Intensive Care, 1st floor, Rao Saheb Achutrao Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra-400053
Mumbai
MAHARASHTRA |
8080041436
drruchiks132@gmail.com |
| Dr Neha Mishra |
Manipal Hospital Old Airport Road |
Room No 703, 7th floor,
#98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA |
8800194111
dr.neham28@gmail.com |
| Dr Deepak Govil |
Medanta-The Medicity |
sector-38, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA |
9818056688
drdeepak_govil@yahoo.co.in |
| Dr Vinod Kumar Singh |
Sir Ganga Ram Hospital |
Room no: 1412, 4th floor, Old Rajinder Nagar, Rajinder Nagar, New Delhi, 110060
North East
DELHI |
9810301011
vinodksingh66@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee Kokilaben Dhirubhai Ambani |
Approved |
| Institutional Ethics Committee, Aster DM Health Care Limited, Aster Medcity, Kochi |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Sri Ganga ram Hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A410||Sepsis due to Staphylococcus aureus, (2) ICD-10 Condition: A411||Sepsis due to other specified staphylococcus, (3) ICD-10 Condition: A412||Sepsis due to unspecified staphylococcus, (4) ICD-10 Condition: A413||Sepsis due to Hemophilus influenzae, (5) ICD-10 Condition: A414||Sepsis due to anaerobes, (6) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (7) ICD-10 Condition: A418||Other specified sepsis, (8) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient must be 18 years or older.
2. Patients with known or suspected blood stream infection based on clinical observations at the time of screening.
3. Patients exhibiting two or more signs of the systemic inflammatory response syndrome (SIRS): SIRS score equal to or more than 2
(SIRS will be diagnosed when two or more of the following criteria will be present: body temperature, more than 38° C (100.4° F) or less than 36° C (96.8° F); heart rate, more than 90 beats per minute; respiratory rate, equal to or more than 22 breaths per minute; white blood cell count, more than 12,000 cells per µl or less than 4,000 cells per µl or altered mental status).
4. Patient should be able to give informed consent if conscious or if patient is unconscious informed consent to be given by family member or LAR
|
|
| ExclusionCriteria |
| Details |
1. Patient less than 18 years of age.
2. Moribund patient expected to die within 24 hours.
3. After Cardiopulmonary resuscitation.
4. Any patient not willing to give informed consent.
5. Subjects requiring less than 24hours admission to the ICU (e.g. post operative patients kept for observation) and those patients who are discharged alive from the ICU without developing sepsis are excluded from the study.
6. Subjects who are mentally unsound and those unwilling to participate in the study will be excluded from the study.
7. Subjects with any other clinically significant unstable medical condition, life-threatening disease, or anything else in the opinion of the Investigator that would interfere with the study results.
8. Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as an exclusion by the Investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sensitivity of GeNei Sepsis Kit for bacterial and fungal identification and detection of AMR genes in the whole blood of patients suspected of sepsis in comparison to conventional Blood Culture method. |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine
• Positive Predictive Value (PPV) & Negative Predictive Value (NPV)
• Turnaround time
• Concordance of the two methods - GeNei Sepsis Kit & Blood Culture
• Clinical utility of GeNeiTM Sepsis Kit
• Antimicrobial resistance gene profile of bacterial pathogens identified in positive samples.
|
4 WEEKS
|
|
|
Target Sample Size
|
Total Sample Size="333"
Sample Size from India="333"
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)
|
10/09/2024 |
| 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="0"
Months="7"
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
|
This study is a prospective, observational, and multicentric study in selected patients, based on the inclusion and exclusion criteria. Subjects are considered enrolled in the study upon signing the Ethics Committee approved Informed Consent Form. A total of 333 subjects will be enrolled in the study, from 3+ sites.
This study is designed to evaluate the Performance and Clinical utility of GeNeiTM Sepsis Kit for identification bacterial and fungal pathogens and detection of AMR genes in comparison to conventional Blood Culture method in patients suspected of sepsis.
Sepsis is a serious condition that can make people very sick and even lead to death. It happens when the body’s response to an infection causes harm to its own tissues and organs. One of the most important things in treating sepsis is quickly figuring out what germ is causing it so doctors can give the right medicine.
Blood culture (BC) is the current `gold standard’ for diagnosing bloodstream pathogens but requires approximately 72 hr to 8 days or more in the case of fastidious bacterial or invasive fungal infection. Sensitivity decreases greatly when antibiotics have been given prior to culture. This delays the start of appropriate antimicrobial therapy and consequently results in worse outcomes and higher mortality rates.
GeNeiTM Sepsis Kit, which yields a significantly higher pathogen (bacterial and fungal) detection with high sensitivity and accuracy. The time to identification can be significantly shortened. The Sepsis kit (Bacterial Pathogen Identification kit) is intended to detect the presence of diverse range of pathogenic Gram-Positive and Gram- Negative bacteria and also detects fungi.
|