| CTRI Number |
CTRI/2020/11/029358 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia |
|
Scientific Title of Study
|
A Prospective, Open label, Single arm, Multi-centric, Investigator initiated study (IIS) for evaluation of efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia (Investigator Initiated Study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCT/01/20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman - Medanta Institute of Critical Care and Anesthesiology |
| Affiliation |
Medanta, The Medicity |
| Address |
1st floor, Institute of Critical Care and Anesthesia, CH Baktawar Singh Rd, near Olympus, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
01244141414 |
| Fax |
|
| Email |
yatinmehta@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Pramit Sonone |
| Designation |
Senior Manager Clinical Operations and PV |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
02226596447 |
| Fax |
|
| Email |
PSonone@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khokan Debnath |
| Designation |
Head – Clinical Operations |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912226596765 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd.
Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai
|
|
|
Primary Sponsor
|
| Name |
Dr Yatin Mehta |
| Address |
Medanta, The Medicity
Institute of Critical Care and Anesthesia,1st Floor,
CH Baktawar Singh Rd, near Olympus, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Wockhardt Ltd |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Brijal Patel |
Hansa Clinic and Hospital |
AMALIA DABHEL Vapi Daman Road, Somnath, Daman, Daman and Diu 396215
Daman
DAMAN & DIU |
9909012179
hansahospital@gmail.com |
| Dr Sachin Shivnitwar |
Lifepoint Multispecialty Hospital |
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune 411057
Pune
MAHARASHTRA |
9730475068
lp.feasibility@gmail.com |
| Dr Balaji More |
Mahatma Gandhi Medical College and Research Institute |
I Block, Ground floor, SBV Campus, Pondicherry – Cuddalore Main Road, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY |
8452959225
clinicalpharmacology@mgmcri.ac.in |
| Dr Yatin Mehta |
Medanta, The Medicity |
Institute of Critical Care
and Anesthesia,1st
floor
CH Baktawar Singh Rd, near Olympus, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA |
01244141414
yatinmehta@hotmail.com |
| Dr Tejasvi Kumar Chikkalingaiah |
Medstar Speciality Hospital |
Ground floor, OPD department, #641/17/1/3, Kodigehalli Main Road,
Sahakarnagar post, Bangalore- 560092, Karnataka, India
Bangalore
KARNATAKA |
9844004187
drchikkalingaiahmedstar@gmail.com |
| Dr Atul Pathak |
Midland Healthcare & Research Center |
Room No 102, Critical care department, B-55 & C-42, Mandir Marg, Mahanagar Extension,
Mahanagar, Lucknow, Uttar Pradesh 226006
Lucknow
UTTAR PRADESH |
8840075252
docbravo2002@gmail.com |
| Dr Anukool Chandra Jain |
Pushpanjali Hospital & Research Center Pvt. Ltd. |
Chest Physician, Department of pulmonary Medicine, Pushpanjali Palace, Delhi Gate, Agra, Uttar Pradesh 282002
Agra
UTTAR PRADESH |
9981537977
dr.anukooljain@gmail.com |
| Dr Kapil zirpe |
Ruby Hall Clinic |
Neuro Critical Care,
40, Sassoon Road,
Pune – 411001,
Maharashtra,
India
Pune
MAHARASHTRA |
9822844212
kapilzirpe@gmail.com |
| Dr Manisha Mendiratta |
Sarvodaya Hospital and Research Centre |
Room No 1008, Basement floor, YMCA Road, Sector 8, Faridabad (India) - 121006
Faridabad
HARYANA
Faridabad
HARYANA |
9599695025
manishagagan@gmail.com |
| Dr Deepak Varade |
Shree Ashirwad Hospital |
C-3/4, Shree Complex,
Opp. Mahavir nagar,
Manpada Road,
Dombivali East, 421201
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
9870409142
deepak.varade@gmail.com |
| DrJagannatha |
Sree Siddhartha Medical College and Research Centre |
OPD block, Department of Surgery,
B.H. Road, Agalkote,
Tumkur, Karnataka, India.
Tumkur
KARNATAKA |
9845305729
drjagannathbhoomi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| HCH Institutional Ethics Committee |
Approved |
| IEC Narayana Diagnostic |
Approved |
| Institutional Ethics committee SArvodaya Hospital & Research Centre |
Approved |
| Institutional Human Ethics Committee MGMCRI |
Approved |
| Institutional Review Board, SSMC |
Approved |
| Lifepoint Research - Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Poona Medical Research Foundation |
Approved |
| Pushpanjali Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levonadifloxacin (IV 800 mg & Tablet 500 mg) |
Levonadifloxacin Intravenous 800 mg twice a day
Levonadifloxacin Tablet 1000 mg twice a day
Total Duration 7-14 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects with 18 years and above of age
2. Subjects must be willing to participate in the study and provide a written informed consent
3. Patient diagnosed with gram positive Bacteremia and to be treated with Levonadifloxacin (IV or Oral) as per investigator’s discretion.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of hypersensitivity to any of the study drugs or same class of drugs
2. Subjects who received any experimental drug within 30 days prior to enrolment
3. Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study
4. Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination or ECG
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical Response
2. Microbiological Response |
1. Day 4, EOT (End of Treatment) and TOC (Test of Cure)
2. EOT End of Treatment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of adverse events
Incidence of serious adverse events
|
Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
26/11/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Publication will be done after study completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Prospective, Open label, Single arm, Multi-centric, Investigator initiated study. This study aims to evaluate efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia.
|