Study of Levonadifloxacin tablet in patients of Bacterial Skin and Skin Structure Infections (ABSSSI)
- Conditions
- Other specified local infections of the skin and subcutaneous tissue,
- Registration Number
- CTRI/2022/04/042295
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
This is Prospective, Single arm,Multi-centric, Phase IV Study for evaluation of safety and efficacy of OralLevonadifloxacin in Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
This study aims to evaluate tolerability,safety and efficacy of oral Levonadifloxacin inAcute Bacterial Skin and Skin Structure Infections (ABSSSI).
Study duration will be approximately 14days for each patient (including 1 day of screening period). Each subject willbe treated for a minimum period of 7 days.
Primary endpoint - Safety evaluationwill be based on adverse events reported, vital signs and physical examinationfindings, clinical laboratory evaluation, and ECG collected during the study
Secondary Endpoint: Overall Clinical Response at the End of therapyvisit. Clinical response will be evaluated on Percentage reduction in lesionsize (measured by the area of redness, oedema or induration) ≥ 20% compared tobaseline
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 280
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (17)
All India Institute of Medical Sciences, AIIMS Bhubaneshwar
🇮🇳Cuttack, ORISSA, India
B J Government Medical College and Sassoon General Hospital,
🇮🇳Pune, MAHARASHTRA, India
Chhetinad Hospital and Research Institute
🇮🇳Chennai, TAMIL NADU, India
Government Medical College Kozhikode
🇮🇳Kozhikode, KERALA, India
Grant Government Medical College & Sir J J Group of Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Hansa Hospital & Clinic
🇮🇳DAMAN, & DIU, India
Institute of Post Graduate Medical Education & Research and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Ishwar Institute of Health Care
🇮🇳Aurangabad, MAHARASHTRA, India
Lifepoint Multispecialty Hospital
🇮🇳Pune, MAHARASHTRA, India
M. V. Hospital for Diabetes Pvt. Ltd.
🇮🇳Chennai, TAMIL NADU, India
Scroll for more (7 remaining)All India Institute of Medical Sciences, AIIMS Bhubaneshwar🇮🇳Cuttack, ORISSA, IndiaDr Prakash Kumar SasmalPrincipal investigator9438884255drpksasmal@gmail.com