NCT01591447已完成2 期
An Open-Label Study to Evaluate the Efficacy and Safety of a Single-Dose of Oral CEM-101 in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative
研究概览
简要总结
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
- •Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
- •Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.
排除标准
- •Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
- •Known HIV, chronic hepatitis B, or hepatitis C infection.
- •Known concomitant infection which would require additional systemic antibiotics.
- •Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
- •Current use of corticosteroid drugs or other immunosuppressive therapy.
- •Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
- •Known significant renal, hepatic, or hematologic impairment.
- •History of intolerance or hypersensitivity to macrolide antibiotics.
- •Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy <30 days).
研究组 & 干预措施
Solithromycin (CEM-101)
Experimental
A single oral dose of 1200 mg solithromycin
干预措施: solithromycin (Drug)
Solithromycin 1000 mg
Experimental
A single oral dose of 1000 mg solithromycin
干预措施: Solithromycin (CEM-101) (Drug)
结局指标
主要结局
The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative
时间窗: 3 to 9 days after study drug dosing
次要结局
- Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea(One day after study drug dosing, and 3 to 9 days after study drug dosing)
- The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)(3 to 9 days after study drug dosing)
- Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens(3 to 9 days after study drug dosing)
- In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated(Baseline and (if applicable) 3 to 9 days after study drug dosing)
- Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens(3 to 9 days after study drug dosing)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With GonorrheaUncomplicated Urogenital GonorrheaNCT02210325Melinta Therapeutics, Inc.264
已完成
3 期
Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial PneumoniaCommunity-acquired Bacterial PneumoniaNCT01756339Melinta Therapeutics, Inc.860
已完成
3 期
Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial PneumoniaCommunity-acquired Bacterial PneumoniaNCT01968733Melinta Therapeutics, Inc.863
招募中
4 期
Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential HypertensionEssential HypertensionNCT05880056Genuine Research Center, Egypt406
招募中
早期 1 期
Evaluation of the Safety, Tolerability and Efficacy of a Gene Therapy Drug for the Treatment of Pediatric Fabry DiseaseFabry DiseaseNCT06207552Children's Hospital of Fudan University6