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CTRI Number  CTRI/2022/06/043031 [Registered on: 06/06/2022] Trial Registered Prospectively
Last Modified On: 13/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EEfficacy and safety of Levonadifloxacin with Teicoplanin-Aztreonam combination in patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) including diabetic foot infection 
Scientific Title of Study   A Prospective, Open label, Randomized, Comparative, Two arm, Multi-centric, Investigator initiated study to evaluate efficacy and safety of Levonadifloxacin with Teicoplanin-Aztreonam combination in patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) including diabetic foot infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ABSSSI/01/2021 V.NO-01-10/12/21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand Nikalje  
Designation  Director and In Charge ICU  
Affiliation  MGM Medical College and Hospital 
Address  Dept of Medicine,7th Floor, MGM Medical College and Hospital,Gate No. 2, MGM Campus, N-6,CIDCO., Aurangabad

Aurangabad
MAHARASHTRA
431 003
India 
Phone  9822496190  
Fax    
Email  anandnikalje@rediffmail.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 MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400 051
India 
Phone  02226596447  
Fax    
Email  PSonone@wockhardt.com  
 
Details of Contact Person
Public Query

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 MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400 051
India 
Phone  02226596407  
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 Anand Nikalje  
Address  Dept of Medicine,7th Floor, MGM Medical College and Hospital,Gate No. 2, MGM Campus, N-6,CIDCO., Aurangabad  
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 Pratik D Ajagekar  Accord Multispeciality Hospital  1/1, Spine road, Santa Nagar, Moshi Pradhikaran, Sector No 4, Pimpri-Chinchwad
Pune
MAHARASHTRA 
9067847843

pratik.ajagekar@gmail.com 
Dr Chandrashekhar Mahakalkar  Acharya Vinoba Bhave Rural Hospital  A Teaching Hospital of Jawaharlal Nehru Medical College , Sawangi (Meghe), Wardha, 442004
Wardha
MAHARASHTRA 
9822369277

cmahakalkar@rediffmail.com 
Dr Vijay Kumar Mishra  Bhagwan Mahavir Medica Super Speciality Hospital  Medica Group of hospitals, Ranchi, Jharkand, 834009
Ranchi
JHARKHAND 
8210059886

vijaykumar.mishra@medicasynergie.in 
Dr K C Soman  Government Medical College Kozhikode  Department of Surgery, Kerala, 673008, India
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 Ilesh Shah  Hansa Clinic and Hospital  Ground Floor, AMALIA DABHEL, Vapi Daman Road, Somnath, Daman, Daman and Diu 396215 Daman DAMAN & DIU
Daman
DAMAN & DIU 
9909015179

hansahospital.cr@gmail.com 
Dr Vinoth Sundaresan  Mahatma Gandhi Medical College and Research Institute, Puducherry  Pondicherry-Cudalore Road, Pilliyarkupam, Puducherry 607402
Pondicherry
PONDICHERRY 
9443667373

vinoths@mgmcri.ac.in 
Dr Haris Mohammed Paravengal  Malabar Medical College Hospital and Research Centre  Malabar Medical College Campus, Ulliyeri, Kerala 673315
Kozhikode
KERALA 
8891576088

pending@gmail.com 
Dr Anand Nikalje  MGM Medical College and Hospital  Dept of Medicine,7th Floor, MGM Medical College and Hospital,Gate No. 2, MGM Campus, N-6,CIDCO., Aurangabad
Aurangabad
MAHARASHTRA 
9822496190

anandnikalje@rediffmail.com 
Dr N Saileshwar  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  OPD No.17, Department of Surgery, Old Belapur road, Kalwa, Thane - 400605
Thane
MAHARASHTRA 
9821474276

nsailesh2000@yahoo.co.uk 
Dr Madhusudan Jaju  Yashoda Hospital  Behind Harihara Kala Bhavan, Secunderabad- 500003 (Telangana)
Hyderabad
TELANGANA 
9440379476

madhu_jaju123@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
HCH Institutional Ethics Committee  Approved 
Institutional Clinical Ethics Committee Kalwa  Approved 
Institutional Ethics Committee Government Medical College Kozhikode  Approved 
Institutional Ethics Committee J.J.Hospital  Approved 
Institutional Ethics Committee Malabar Medical College Hospital  Submittted/Under Review 
Institutional Ethics Committee of Sai Sneh Hospital and Diagnostic Centre  Approved 
Institutional Ethics Committee, JNMC, DMIHER, Wardha  Submittted/Under Review 
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT  Not Applicable 
Yashoda Academy of Medical Education and Research - IEC  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levonadifloxacin Injection 800 mg Levonadifloxacin tablet 500 mg   Levonadifloxacin IV 800 mg will be administered twice in a day 11±1 hours apart. One dose of IP will be infused over a period of approximately 90 mins. Levonadifloxacin Oral 1000 mg will be administered twice in a day, 11±1 hours apart upto 14 days  
Comparator Agent  Teicoplanin-Aztreonam  Teicoplanin will be administered 400 mg (approximately 6 mg/kg body weight) every 12 hours for initial 3 intravenous/ intramuscular administration as loading dose. Teicoplanin will be administered 400 mg (approximately 6 mg/kg body weight) intravenous/ intramuscular administration once a day as maintenance dose. Aztreonam will be administered 2 g every 12 hours by intravenous route once a day upto 14 day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult subjects of any gender ≥18 years
2. Subjects must be willing to participate in the study and provide a written informed consent
3. Subjects with diagnosed ABSSSI (requiring hospitalization) characterized by any of the following infection types:
a. Cellulitis / Erysipelas: diffuse skin infection characterized by spreading areas of redness, oedema and induration
b. Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, oedema and / or induration
c. Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that was accompanied by redness, oedema and/or induration
d. Diabetic foot infection
4. Subjects with lesion size area of at least 75 cm2, lesion size was measured by the area of redness, oedema or induration
5. Subjects with suspected and / or documented evidence of Gram positive infection
 
 
ExclusionCriteria 
Details  1.Subjects with history of hypersensitivity to any of the study drugs or same class of drugs
2.Subjects who have received prior antibiotic therapy within the past 24 hours for the treatment of a current episode of ABSSSI. Followings are the exception to these criteria:
a.Subjects who have received a single dose of short acting antibacterial drug within 24 hours of enrolment
b.Subjects 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 who received any experimental drug within 30 days prior to enrolment
4.Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study
5.Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination, or ECG,
6.Subjects on hemodialysis or creatinine clearance ≤ 30 mL/min (estimated by Cockcroft Gault equation).
Subjects with abnormal platelet count < 1,50,000 cells/mm3
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical success rate at TOC (Test of Cure) visit  Day 7±1 to 14 from initiation of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical success rate at EOT (End of Treatment)
visit i.e. Day 7±1 to 14
Clinical improvement rate at visit 2 (Early
Assessment visit) i.e. Day 4±1 from initiation of
therapy
Microbiological success rate at EOT (End of
Treatment) visit
Safety – Tolerability Endpoint: Incidence of
adverse events or serious adverse events
Incidence of Nephrotoxicity & Incidence of
Thrombocytopenia 
Day 7±1 to 14
Day 4±1 from initiation of therapy
Day 7±1
up to Day
14
Throughout the study 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   15/06/2022 
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="0"
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 a Prospective, Open label, Randomized, Comparative, Two arm, Multi-centric, Investigator initiated study in hospitalized patients of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) including diabetic foot infection

This study aims to efficacy and safety of Levonadifloxacin and Teicoplanin-Aztreonam combination in hospitalized patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI). 

Minimum Duration of treatment will be 7 days. (Duration of treatment can be extend upto 14 days as per investigator’s discretion.)

Primary endpoint : Clinical success rate at TOC (Test of Cure) visit

Secondary endpoint : Clinical success rate at EOT (End of Treatment) visit 

Clinical improvement rate at visit 2 (Early Assessment visit) 

Microbiological success rate at EOT (End of Treatment) visit

Safety – Tolerability Endpoint: Incidence of adverse events / serious adverse events (Incidence of Nephrotoxicity) & Incidence of Thrombocytopenia

 


 
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