A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Success at Test Of Cure Visit
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.
详细描述
This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI).
Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern.
Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment.
Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the blinded observer will be unaware of the treatment assigned to patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged more than 18 years.
- •Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep SSI according to the CDC definition.
- •The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.
排除标准
- •Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.
- •Any infection expected to require systemic antimicrobial agents other than study treatment(s).
- •Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs
- •Medical history of central nervous system (CNS) disorders
- •Medical history of myasthenia gravis.
- •Medical history of C. difficile diarrhea.
- •Organ-space infection.
- •Complicated Intra-Abdominal Infection (cIAI)
- •Chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with SSI healing.
- •Underlying disease leading to deep immunosuppressive status.
- •End-stage renal disease, CrCl <15 mL/min.
研究组 & 干预措施
Delafloxacin
Delafloxacin IV, with the option to switch to delafloxacin oral
干预措施: Delafloxacin (Drug)
Best Available Therapy
Cardiothoracic / related leg SSI
- Vancomycin IV
- Linezolid IV, with the option to switch to linezolid oral.
In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice
Abdominal SSI
- Piperacillin/Tazobactam IV, OR
- Tigecycline IV
In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.
干预措施: Vancomycin (Drug)
Best Available Therapy
Cardiothoracic / related leg SSI
- Vancomycin IV
- Linezolid IV, with the option to switch to linezolid oral.
In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice
Abdominal SSI
- Piperacillin/Tazobactam IV, OR
- Tigecycline IV
In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.
干预措施: Linezolid (Drug)
Best Available Therapy
Cardiothoracic / related leg SSI
- Vancomycin IV
- Linezolid IV, with the option to switch to linezolid oral.
In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice
Abdominal SSI
- Piperacillin/Tazobactam IV, OR
- Tigecycline IV
In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.
干预措施: Piperacillin/Tazobactam (Drug)
Best Available Therapy
Cardiothoracic / related leg SSI
- Vancomycin IV
- Linezolid IV, with the option to switch to linezolid oral.
In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice
Abdominal SSI
- Piperacillin/Tazobactam IV, OR
- Tigecycline IV
In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.
干预措施: Tigecycline (Drug)
结局指标
主要结局
Number of Participants With Clinical Success at Test Of Cure Visit
时间窗: 7-14 days after last dose
Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions: * Cure: The complete resolution of all baseline signs and symptoms of SSI * Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.
次要结局
- Hospital Infection Related Length of Stay (IRLOS)(up to 14 days)
- Hospital Length of Stay (LOS)(up to 45 days (Late Follow Up visit))
- Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment(up to 14 days)
- Microbiological Response(up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit))