An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria Gonorrhoeae on the Resistome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Macrolide Resistance Determinants
研究概览
简要总结
In this Randomized Controlled Trial, the investigators will recruit 42 men attending the STI and HIV clinic at the Institute of Tropical Medicine, with a diagnosis of N. gonorrhoeae and randomize them 1:1 to receive either ceftriaxone or ceftriaxone/azithromycin. They will be followed-up for a test of cure visit at day 14 post-treatment where urine, oropharyngeal and anorectal samples will be taken to test for cure and monitor treatment effects on the microbiome and resistome. The primary outcome will be evaluating the difference in the abundance of resistance conferring genes in the rectal microbiome in the two arms, 14 days after the receipt of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rocephine®
ceftriaxone 1g + lidocaine 35mg; intramuscular injection
干预措施: Rocephin (Drug)
Rocephine® + Azithromycin
ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally
干预措施: Rocephin (Drug)
Rocephine® + Azithromycin
ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally
干预措施: Azithromycin (Drug)
结局指标
主要结局
Macrolide Resistance Determinants
时间窗: Day 14
During the bioinformatic analyses, each identified antibiotic-resistance determinant will be categorized at the class level using a read-based classification tool. The primary outcome will be the ratio of mean macrolide resistance determinants in the day 14 anorectal samples between the two treatment groups. This ratio will be calculated by dividing the mean normalized read count of macrolide- resistance determinants categorized at the class level in the Ceftriaxone/Azithromycin group by the corresponding mean quantity in the Ceftriaxone group.
次要结局
- Read Count of Resistance Determinants for Each Non-macrolide Antibiotic Class(Day 14)
- Acquisition of Phenotypic Resistance to Azythromycin by N. Gonnorrhea(Day 0 and Day 14)