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).
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 17
- 主要终点
- Safety evaluation will be based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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 cm
- •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.
排除标准
- •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.
结局指标
主要结局
Safety evaluation will be based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study
时间窗: 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)
次要结局
- 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)