EUCTR2018-001082-17-IT进行中（未招募）1 期
A randomized, observer-blinded, active-controlled, Phase IIIb study to compare IV / Oral delafloxacin fixed-dose monotherapy with best available treatments in a microbiologically enriched population with surgical site infections - DRESS - DELAFLOXACIN INTRAVENOUS AND ORAL MONOTHERAPY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients aged more than 18 years.
- •2. 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 SSI according to the CDC definition1, namely:
- •- Superficial Incisional Surgical Site Infection, involving only skin and subcutaneous tissue of the incision, and at least one of the following local findings:
- •· purulent drainage from the superficial incision;
- •· organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision;
- •· superficial incision is deliberately explored by surgeon AND the patient has at least one of the following signs or symptoms of infection:
- •* pain or tenderness,
- •* localized swelling,
- •* redness or heat;
- •· diagnosis of superficial incisional SSI made by the Investigator.
- •- Deep Incisional Surgical Site Infection, involving deep soft tissues (e.g. fascia and muscle layers) at the incision site and at least one of the following findings:
- •· purulent drainage from the deep incision but not from the organ / space component of the surgical site;
- •· a deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms of infection:
- •* fever (> 38 °C),
- •* localized pain or tenderness;
- •· an abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination;
- •· diagnosis of deep incisional SSI made by the Investigator.
- •3. The severity of infection requires an IV treatment and patient hospitalization according to the Investigator’s judgment.
- •4. Females participating in the study must be either:
- •- Females of non-childbearing potential, defined as any woman who underwent surgical sterilization or is more than 2 years post-menopausal;
- •- Females of childbearing potential provided that they have a negative pregnancy test at Screening and are routinely using highly effective birth control methods and continue up to 30 days after last dose of study treatment. Such methods include:
- •- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- •- progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
- •- intrauterine device (IUD)
- •- intrauterine hormone-releasing system ( IUS)
- •- bilateral tubal occlusion
- •- vasectomised partner
- •- sexual abstinence
- •1 Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success.
- •2 Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse up to 30 days after last dose of study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject.
- •5. Males participating in the study must agree either to abstain from sexual intercourse or to use an effective method of contraception as sterilization – vasectomy – or condom in combination with a spermicidal cream up 30 days after last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 478
排除标准
- •1. Previous IV antimicrobial therapy exceeding 24 hour duration administered during 72 hours prior to the first dose of study treatment.
- •2. Any infection expected to require systemic antimicrobial agents other than study treatment(s)
- •5. Medical history of myasthenia gravis.
- •6. Medical history of C. difficile diarrhea.
- •8. Organ-space infection.
- •13. Use of systemic corticosteroids for more than 10 days at a dose equivalent to more than 15 mg prednisolone in the previous 2 weeks.
- •14. Patients with end-stage renal disease on hemodialysis or peritoneal dialysis or creatinine clearance (CrCl) < 15 mL/min using the Cockcroft-Gault formula.
- •15. Pregnant and/or breastfeeding women.
研究者
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