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
|
|
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
|