| CTRI Number |
CTRI/2020/11/029258 [Registered on: 20/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| 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 Community Acquired Bacterial Pneumonia (CABP). |
|
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 Community Acquired Bacterial Pneumonia (CABP). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CABP/01/20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B P Singh |
| Designation |
Director |
| Affiliation |
Midland Healthcare and Research Center |
| Address |
Room No 104 Department of Pulmonology B55 and C42 Mandir Marg Mahanagar Extension, Mahanagar Lucknow Uttar Pradesh 226006
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH
226006
India |
| Phone |
9415011669 |
| Fax |
|
| Email |
bps2159@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaishid Adhal |
| Designation |
Head Medical Affairs Antibiotic Discovery |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Towers Bandra Kurla Complex Bandra 400 051 Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9930696711 |
| Fax |
|
| Email |
jadhal@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khokan Debnath |
| Designation |
Head of Clinical Operations Regulatory Affairs Pharmacovigilance |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Towers Bandra Kurla Complex Bandra 400 051 Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596765 |
| 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 B P Singh |
| Address |
Midland Healthcare & Research Center
B 55 and C 42, Mandir Marg, Mahanagar Extension,
Mahanagar, Lucknow, Uttar Pradesh 226006
|
| 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 = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shirkant Deshpande |
Ashirwad Hospital |
Next to 32 Maratha section, Krishna Nagar, Ulhasnagar 421004, Thane
Thane
MAHARASHTRA |
9822017445
writetoshrikant@rediffmail.com |
| Dr Rahul Kumar Rathore |
Charak Hospital and Research Centre |
2nd Floor, Department of Pulmonary Medicine
Hardoi Rd, near Safaid Masjid, Dubagga, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
7408441522
drrahulkgmu85@gmail.com |
| Dr Shubhangi Deshpande |
GMERS Medical College and General Hospital |
6th floor, Department of Medicine, Old TB hospital Campus, Gotri Rd, Gotri, Vadodara Gujarat 390021
Vadodara
GUJARAT |
7878081208
Shubhangi311@yahoo.com |
| Dr Chintan Patel |
Hansa Clinic and Hospital |
AMALIA DABHEL, Vapi Daman Road, Somnath, Daman, Daman and Diu 396215
Daman
DAMAN & DIU |
9909012179
hansahospital@gmail.com |
| Dr Jigar Mehta |
Kusum Dhirajlal Hospital |
1st floor, OPD, Kusum Dhirajlal Hospital, Vaishnodevi Circle, SG Road, Ahmedabad, 382421
Ahmadabad
GUJARAT |
9825026577
drjigar74@yahoo.com |
| Dr Rajkumar Nikalje |
Lifepoint Multispecialty Hospital |
145/1, Mumbai Bangalore Highway,Near Hotel Sayaji, Wakad, Pune 411 057
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 Hirenappa Undnur |
Medstar Speciality Hospital |
2270, Maruthi Plaza, Kodegehalli Main Road, Sahakarnagar, Bangalore 560 092
Bangalore
KARNATAKA |
08041127524
medstarclinicalresearch@gmail.com |
| Dr B P Singh |
Midland Healthcare and Research Center |
Room No 104 Department of Pulmonology B55 and C42 Mandir Marg Mahanagar Extension,
Mahanagar Lucknow Uttar Pradesh 226006
Lucknow
UTTAR PRADESH |
9415011669
bps2159@yahoo.com |
| Dr Ravi Kumar |
R P Chest Hospital |
OPD No 1, Ground Floor, Pulmonology,
Bairaveshwara complex behind, Brigade Millenium Road, Paradise Colony, Phase 7, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA |
7022247227
rpchest.ravi@gmail.com |
| Dr Manisha Mendiratta |
Sarvodaya Hospital and Research Centre |
Room No 1008, Basement floor, YMCA Road, Sector 8, Faridabad (India) - 121006
Faridabad
HARYANA |
8800493025
s.nair55@gmail.com |
| Dr Abhijit Telkhade |
Shree Ashirwad Hospital |
Pulmonology department, C/3, Shree Complex, Manpada Road, Domibvali 421201
Thane
MAHARASHTRA |
7773950110
drabhijit.telkhade@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Altezzza Institutional Ethics Committee |
Approved |
| Ashirwad Ethics Committee |
Approved |
| HCH Institutional Ethics Committee |
Approved |
| IEC Ashraya Medinova Pvt Ltd |
Approved |
| IEC Narayana Diagnostic |
Approved |
| Institutional Ethics Committee Charak Hospital and Research Centre |
Approved |
| Institutional Ethics committee SArvodaya Hospital & Research Centre |
Approved |
| Institutional Human Ethics Committee GMERS Vadodara |
Approved |
| Institutional Human Ethics Committee MGMCRI |
Approved |
| KD Hospital Institutional Ethics Committee |
Approved |
| Lifepoint Research - Ethics Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J159||Unspecified bacterial pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levonadifloxacin (IV 800 mg and Tablet 500 mg) |
Levonadifloxacin IV 800 mg twice a day
Levonadifloxacin tablet 1000 mg twice a day
Total duration 5-14 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 Community Acquired Bacterial Pneumonia (CABP) 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. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure)
2. Microbiological response on EOT (End of Treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of adverse events
Incidence of serious adverse events
|
baseline, Visit 2, Visit 3 and Visit 4 |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
23/11/2020 |
| 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 Community Acquired
Bacterial Pneumonia (CABP).
Duration of treatment will be 5-7 days.
(Duration of treatment can be extend upto 14 days in concurrent bacteremia as
per investigator’s discretion.)
Primary endpoint - Clinical Response in
a subject is defined as: Cure, failure and Indeterminate
Microbiological response is defined as: Cure, failure and Indeterminate |