CTRI/2022/04/042295 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On:
18/01/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Study of Levonadifloxacin tablet 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 Oral Levonadifloxacin in Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
WOC/LEV/CT-11/19, Version NO 02, Dated: 23 Mar 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)
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 Grant Government Medical College and Sir J.J.Group of Hospitals
Approved
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
Lifepoint Research 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
Status
Approved/Obtained
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 tablets 500 mg
Levonadifloxacin 1000 mg will be administered twice in a day, 11±1 hours apart.
Comparator Agent
None
None
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
ExclusionCriteria
Details
1. ABSSSI meeting any of the following criteria:
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 the 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="280" Sample Size from India="280" 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)
10/05/2022
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 Oral
Levonadifloxacin in Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
This study aims to evaluate tolerability,
safety and efficacy of oral 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