Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 254
- 主要终点
- Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)
研究概览
简要总结
Since the use of antibiotics, Neisseria Gonorrhoeae (NG) has acquired progressive resistance to penicillins, sulfonamides, tetracyclines and quinolones. The oropharynx is recognized as an important site for DNA exchange between NG and other commensal Neisseria, allowing NG to acquire new antimicrobial resistance. Despite the worrying data on the emergence of resistant NG, the recommendations remain to systematically treat these infections with ceftriaxone, including asymptomatic pharyngeal localizations. The objective of our study is to evaluate a ceftriaxone sparing strategy in order to limit the emergence of antibiotic resistance.
The primary objective of the study is to evaluate the clearance of Neisseria gonorrhoeae, 3 months after the diagnosis of asymptomatic pharyngeal carriage documented on nucleic acid amplification test (NAAT).
详细描述
Non-inferiority, multicenter, prospective, randomized open-label study, in two parallel arms, comparing the pharyngeal clearance of Neisseria gonorrhoeae (NG) at 3 months with or without treatment with ceftriaxone.
Experimental group: Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to Sexually Transmitted Infection or positive Polymerase chain reaction (PCR) at 3 months)
Control group: Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal Polymerase chain reaction (PCR) again positive for NG during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients : Absence of antibiotic treatment
干预措施: Absence of antibiotic treatment (Other)
Patients : Ceftriaxone
干预措施: Ceftriaxone (Drug)
结局指标
主要结局
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)
时间窗: 3 months after inclusion
次要结局
- Proportion of patients with negative pharyngeal NG cultures(at 3 months after inclusion)
- Proportion of partners with Resistant NG strains(Up to 3 months)
- Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)(at 1 month after inclusion)
- Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)(at 3 months after inclusion)
- Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae(at 3 months after inclusion)
- Proportion of patients with Resistant NG strains(Up to 3 months)
- Proportion of patients with spontaneous pharyngeal clearance of NG(at 3 months after inclusion)
- Proportion of partners with NAAT positive for NG(at 3 months after inclusion of the partner)
- Proportion of partners with NG cultures positive(at 3 months after inclusion of the partner)
- Proportion of identical genome between partner and patient(Up to 3 months)
- Proportion of adverse events(Up to 3 months)