| CTRI Number |
CTRI/2022/05/042698 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| 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 Injection in patients of Bacterial Skin and Skin Structure Infections (ABSSSI). |
|
Scientific Title of Study
|
A Prospective, Single arm, Multi-centric, Phase IV Study for evaluation of safety and efficacy of Intravenous Levonadifloxacin in Acute Bacterial Skin and Skin Structure Infections (ABSSSI). |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| WOC/LEV/CT-01/21, Ver. 02,08 Sep2021 Amed 01, 08 Oct.2025 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Senior General Manager (Head) RA, Clinical Operations, PV, QA and compliance (India and Emerging Market) |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra 400 051, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596407 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Anindita Chatterjee |
| Designation |
Medical Monitor |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers Bandra Kurla Complex Bandra – 400 051 Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596415 |
| Fax |
|
| Email |
AChatterjee@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Kaushal Kapadia |
| Designation |
Sr. Manager Clinical Operations |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596445 |
| Fax |
|
| Email |
KKapadia@wockhardt.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Ltd |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash Kumar Sasmal |
All India Institute of Medical Sciences Bhubaneswar |
AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha, India, 751019
Cuttack
ORISSA |
9438884255
drpksasmal@gmail.com |
| Dr Amol Kholamkar |
Graavity Multispecialty Hospital Pvt. Ltd |
4th floor, Shree Harikrishna Plaza, Opp.Old Adgaon Naka Depot, Panchavati, Nashik-422003, Maharashtra, India
Nashik
MAHARASHTRA |
94489 85679
Dramolkholamkar.graavitycr@gmail.com |
| Dr Illesh Shah |
Hansa Hospital & Clinic |
AMALIA - DABHEL, Vapi - Daman Road, Somanth, Daman, 396215
Mumbai
MAHARASHTRA |
9909015179
hansahospital.cr@gmail.com |
| Dr Shrikant Kurhade |
K.K. Care Multispeciality |
Wadmukhwadi, Charholi Budruk, Pune-412105
Pune
MAHARASHTRA |
8308601888
shrikantkurhade@gmail.com |
| Dr Niraj Chawda |
Nand Hospital |
Near Panchmukhi Hanuman Temple, Vasna Bhagli road, Next to shantidham Society
Vadodara
GUJARAT |
9909007791
drnirajchawdaicr@gmail.com |
| Dr Amitava De |
Nil Ratan Sarkar Medical College and Hospital, |
138, A.J.C Bose Road, Kolkata-700014, West Bengal, India
Kolkata
WEST BENGAL |
8777825690
amitava.plastic@gmail.com |
| Dr Naman Patel |
OHM Hospital |
41/A, Karmacharinagar-1, Opp. Alakapuri Society, Ghatlodia, Ahmedabad
Ahmadabad
GUJARAT |
9712364224
ohmhospital@gmail.com |
| Dr Pravin Kamble |
Sai Krupa Hospital |
Renuka Corner Tapkir Chowk, Thergaon, Pune
Pune
MAHARASHTRA |
9372074767
drpravinkamble@gmail.com |
| Dr Hakim Barot |
Saifee Hospital |
Box 3771,15/17 Maharishi Karve Marg Mumbai 400004 Maharashtra India
Mumbai
MAHARASHTRA |
9820331278
drhakimbarot@gmail.com |
| Dr Shalabh Gupta |
Santosh Medical College and Hospital |
Ambedkar road, Maliwara, Nehru Nagar, Ghaziabad
Ghaziabad
UTTAR PRADESH |
9811965686
Shalabhgupta19@gmail.com |
| DR Abhishek Arun |
Shekhar Hospital, Pvt. Ltd |
Church Rd, B Block, Indira Nagar Lucknow - 226016, Uttar Pradesh, India.
Lucknow
UTTAR PRADESH |
9455388302
Dr.abhishekarun@gmail.com |
| Dr Jayesh Rajpura |
Siddhi I.C.U. and Multispecialty Hospital |
Nirali Building, Dandia Bazar road, Near Maharani girl’s high school, Vadodara – 390001, Gujrat, India
Vadodara
GUJARAT |
9825594931
drjayeshclinicaltrials@gmail.com |
| Dr Gopinatha H V |
Subbaiah Institue of Medical Science |
H.H. road, Purle, Shivamogga-577222,
Karnataka, India.
Shimoga
KARNATAKA |
94489 85679
hvgnath@gmail.com |
| Dr Mukesh Kumar Maheshwari |
Subharti Medical College and Hospital |
NH – 58, Delhi Haridwar Bypass road, Meerut – 250005, Uttar Pradesh, India
Meerut
UTTAR PRADESH |
9897002632
Mk_maheshwari58@yahoo.co.in |
| Dr Pranam Sadawarte |
Taywade Multispeciality Hospital |
Beltarodi Road, Chowk, Babulkheda, Nagpur – 440027
Nagpur
MAHARASHTRA |
7276771181
drpranamsadawarte01@gmail.com |
| Dr Sandeep Desai |
Valsad Institute of Medical Science, |
NH 48, Parnera Pardi, Valsad – 396007, Gujrat, India
Valsad
GUJARAT |
9825120393
Sandeep_desai@vimsl.co.in |
| Dr Sunil Kumar V |
Victoria Hospital, Bangalore Medical College & Research Institute, |
Mysore road, New City Market, New Theragupet, Bangalore-560002
Bangalore
KARNATAKA |
7702692660
sunildocv@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics Committee |
Approved |
| Anand Institutional Ethics Committee |
Approved |
| Central Independent Ethics Committee-CIEC |
Approved |
| Ethics Committee Bangalore Medical College & Research Institute. |
Approved |
| Ethics Committee of Ishwar Institute of Health Care |
Approved |
| Ethics Committee Subbaiah Institute of Medical Sciences |
Approved |
| Ethics Committee, N.R.S. Medical College NRS Medical College And Hospital |
Approved |
| HCH Institutional Ethics Committee |
Approved |
| HCH Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee AIIMS Bhubaneshwar |
Approved |
| Institutional Ethics Committee of New Healthcare Nursing Home |
Approved |
| Institutional Ethics Committee, Shekhar Hospital |
Approved |
| Institutional Ethics Committee, Subharti Medical College and Hospital |
Approved |
| OHM Hospital Ethics Committee |
Approved |
| Saifee Hospital Institutional Review Board |
Approved |
| Saikrupa Hospital Institutional Ethics Committee |
Approved |
| Treat Me Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levonadifloxacin IV 800 mg |
Levonadifloxacin 800 mg will be administered twice in a day 11±1 hours apart to a maximum of 14 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects of 18 to 65 years of age (both inclusive)
2. Subjects must be willing to participate in the study and provide a written informed consent
3. Subjects of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including diabetic foot infections
4. Subjects with lesion size area of at-least 75 cm2. Lesion size will be measured by the area of redness, oedema, or induration
5. Subjects with suspected Gram positive infection clinically and/or documented evidence of Gram-positive infection
6. Subjects who required intravenous (IV) therapy as per Investigator’s discretion or where oral administration was not feasible
|
|
| ExclusionCriteria |
| Details |
1. a. Clinically diagnosed with impaired blood supply (such that the likelihood of amputation of the infected anatomical site is likely)
b. ABSSSI expected to require prolonged antimicrobial therapy as per the discretion of the Investigator
c. Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene
d. ABSSSI requiring surgical intervention (except surgical incision and drainage for abscess)
2. Subjects who have received prior antibiotic therapy within past 24 hours for the treatment of a current episode of ABSSSI. Following are the exception to this criteria:
a. Subjects who have received a single dose of short acting antibacterial drug within 24 hours of enrolment
b. Subject with evidence of clinical progression of ABSSSI while on antibacterial drug therapy after at least 48 hours
c. Subjects who have received an antibacterial drug for surgical prophylaxis and subsequently developed ABSSSI
3. Subjects with any clinically significant abnormalities in pulmonary, gastrointestinal, endocrine (excluding diabetes mellitus), hepatic or renal systems
4. Subjects with history of seizures
5. Subjects with history of hypersensitivity to any of the study drugs or same class of drugs
6. Sexually active subjects, who are not willing to use contraceptive methods (e.g., hormonal contraceptives, intrauterine devices, barrier method) and pregnant or lactating women
7. Subjects who received any experimental drug within 30 days prior to enrolment
8. Subjects with second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, significant ECG abnormalities including QTc ≥ 450 msec
9. Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study
10. Subjects with neoplastic disorder which is either active or has been in remission for less than one year or treatment with antineoplastic drugs within the past 6 months
11. Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, physical examination or ECG |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety evaluation will be based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study |
Baseline, Visit 2 (Day 4±1 from initiation of therapy, Visit 3 (Day 7±1 from initiation of therapy, Visit 4 (Day 7±1 up to Day 14 from initiation of therapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Clinical Response at the End of therapy visit. Clinical response will be evaluated on Percentage reduction in lesion size (measured by the area of redness, oedema or induration) ≥ 20% compared to baseline |
End of Therapy Visit |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
This is Prospective, Single arm,
Multi-centric, Phase IV Study for evaluation of safety and efficacy of Intravenous
Levonadifloxacin in Acute Bacterial Skin and Skin Structure Infections
(ABSSSI).
This study aims to evaluate tolerability,
safety and efficacy of Intravenous Levonadifloxacin in Acute Bacterial Skin and Skin Structure Infections
(ABSSSI).
Study duration will be approximately
14 days for each patient (including 1 day of screening period). Each subject
will be treated for a minimum period of 7 days.
Primary endpoint - Safety evaluation
will be based on adverse events reported, vital signs and physical
examination findings, clinical laboratory evaluation, and ECG collected
during the study
Secondary Endpoint: Overall Clinical
Response at the End of therapy visit. Clinical response will be evaluated on
Percentage reduction in lesion size (measured by the area of redness, oedema
or induration) ≥ 20% compared to baseline
|
|