| CTRI Number |
CTRI/2022/05/042698 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| 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
|
| Secondary ID |
Identifier |
| WOC/LEV/CT-01/21, Version 02, 08 Sep 2021 |
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 and QA (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. Purushotham |
| Designation |
Medical Monitor |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers Bandra Kurla Complex Bandra – 400 051 Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596447 |
| Fax |
|
| Email |
purushothamVS@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Kaushal Kapadia |
| Designation |
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 Lata Bhoir |
B J Government Medical College and Sassoon General Hospital |
Department of Surgery, Near Railway Station, Agarkar nagar, Jaiprakash Narayan Road, Pune, Maharashtra – 411 001
Pune
MAHARASHTRA |
9552189336
lbhoir03@gmail.com |
| Dr R Anantharamakrishnan |
Chettinad Hospital and Research Institute |
Rajiv Gandhi Salai, Kelambakkam, Tamil Nadu, India 603103
Chennai
TAMIL NADU |
7736050004
drarkrishnan03@gmail.com |
| Dr K C Soman |
Government Medical College |
Department of Surgery, Kozhikode, Kerala, India 673008
Kozhikode
KERALA |
9778225561
drsomanresearch@gmail.com |
| Dr Amol Nanasaheb Wagh |
Grant Government Medical College & Sir J J Group of Hospital |
OPD No. 5, Department of General Surgery, Byculla, Mumbai 400008
Mumbai
MAHARASHTRA |
9820685368
dramolwagh@gmail.com |
| Dr Illesh Shah |
Hansa Hospital & Clinic |
AMALIA - DABHEL, Vapi - Daman Road, Somanth, Daman, 396215
Mumbai
MAHARASHTRA |
9909015179
hansahospital.cr@gmail.com |
| Dr Arindam Sarkar |
Institute of Post Graduate Medical Education & Research and SSKM Hospital |
Department of plastic surgery, 244 AJC Bose Road, Kolkota West Bengal, India, 700020
Kolkata
WEST BENGAL |
9831187557
doctor.asarkar@gmail.com |
| Dr Suresh Harbade |
Ishwar Institute of Health Care |
Ishwar Heights, Plot No 7, Gut No 6/1, Beside Punajbi Bhawan, Padegaon, Auranagabd, Maharashtra, India 431002
Mumbai
MAHARASHTRA |
9890069313
ishwarhealthcare@gmail.com |
| Dr Dighvijay Jadhav |
Lifepoint Multispecialty Hospital |
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune – 411 057, Maharashtra India
Mumbai
MAHARASHTRA |
7972169946
digvijayjadhav621@gmail.com |
| Dr G Senthil |
M.V.Hospital for Diabetes Pvt. Ltd. |
#4, West Madha Church Street, Royapuram, Chennai 600013
Chennai
TAMIL NADU |
9840067251
senaakee@yahoo.co.in |
| Dr Vinoth S |
Mahatma Gandhi Medical College and Research Institute |
Pndicherry - Cuddalore Road, East Coast Road, Pillayarkupam, Puducherry 607402
Pondicherry
PONDICHERRY |
9443667373
vinoths@mgmcri.ac.in |
| Dr Nishith Gandhi |
Medistar Multispeciality Hospital |
Trimurti Avenue, Medistart cross road, National Highway - 8, Industrial Area, Himatnagar, Gujarat - 383001
Ahmadabad
GUJARAT |
9825618968
drnishithgandhi@yahoo.co.in |
| Dr Sanjay Maitra |
Nil Ratan Sircar Medical College and Hospital |
Department of Surgery, 138 A.J.C Bose Road, Kolkata, West Bengal, India 700014
Kolkata
WEST BENGAL |
9830582835
drsanjaymaitra@gmail.com |
| Dr Laxmi Narayan Mittal |
Priyadarshani Nursing Home |
OPD 1-3, 1st Floor, M-Baria Estate, Opp. Manvel Pada Talav, Kargil Nagar Road, Virar (E), 401305
Mumbai (Suburban)
MAHARASHTRA |
9821182559
lnmittal1311@gmail.com |
| Dr Raman Gaikwad |
Sahyadri Super Speciality Hospital |
30C, Erandwane, Karve Road, Pune 411004, Maharashtra, India
Pune
MAHARASHTRA |
8551891075
Raman.gaikwad@sahyadrihospitals.com |
| Dr Ruchir Shah |
Sanjivani Superspeciality Hospital Pvt. Ltd. |
1 Uday Park Society, Near Sunrise Park, Vastrapur, Ahmedabad, Gujarat - 380015
Ahmadabad
GUJARAT |
9904479691
drruchirshah.dermatologist@gmail.com |
| Dr Chetan Shantilal Lalseta |
Shree Giriraj Multispeciality Hospital |
27-Navjyot Park Corner, 150 Feet Ring Road, Rajkot – 360005, Gujarat, India
Rajkot
GUJARAT |
9825199585
chetanlalseta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Ethics Committee - Prof. M. Viswanathan Diabetes Research Centre |
Approved |
| Ethics Committee N.R.S Medical College |
Submittted/Under Review |
| Ethics Committee of B J Government Medical College and Sassoon General Hospital |
Submittted/Under Review |
| Ethics Committee of Ishwar Institute of Health Care |
Approved |
| HCH Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee AIIMS Bhubaneshwar |
Approved |
| Institutional Ethics Committee Government Medical College Kozhikode |
Approved |
| Institutional Ethics Committee Grand Goverment Medical College and Sir J.J.Group of Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee IPGME&R |
Approved |
| Institutional Ethics Committee Nilratan Sircar Medical College |
Approved |
| Institutional Ethics Committee of New Healthcare Nursing Home |
Approved |
| Institutional Human Ethics Committee for faculty research |
Approved |
| Institutional Human Ethics Committee MGM Pondicherry |
Approved |
| LPR Ethics Committee |
Approved |
| Medistar Hospital Ethics Committee |
Approved |
| Sahyadri Hospitals Pvt. Ltd. Ethics Committee |
Submittted/Under Review |
| Sanjivani Hospital Ethics Committee |
Approved |
| Shree Giriraj Hospital Research 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)
|
22/05/2022 |
| 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
|
|