NCT04946500Unknown不适用
Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Failure of Clindamycine
研究概览
简要总结
The alternatives to the combination of Fluoroquinolone and Rifampicin in prosthetic joint infections (PJI) caused by staphylococcus are currently unclear. Clindamycin is prescribed as dual therapy in this indication, and provides many advantages. We conducted a multicenter retrospective observational study evaluating the efficacy and safety of Clindamycin in prosthetic joint infections due to staphylococcus between January 2013 and December 2019.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with PJI defined according to the IDSA.
- •Infection must be mono-microbial or multi-microbial with Staphylococcus spp sensitive to Clindamycin.
- •Infection may be acute or chronic, nosocomial or community-acquired.
- •Patient having received a curative treatment with Clindamycin.
排除标准
- •Patients with osteitis, osteomyelitis, septic arthritis in native joints, diabetic foot infections, spondylodiscitis, infections in external fixator, surgical site infections following neurosurgical management, bedsores, skin and soft tissue infections.
- •Patients with mono-microbial infections other than Staphylococcus, multi-microbial infections including other bacteria than Staphylococcus, suspected Osteoarticular Infection without microbial identification.
- •Patients with clindamycin-resistant Staphylococcal PJI, constitutive MLSb phenotype.
- •Patients having received suspensive treatment with Clindamycin.
- •Patients treated with Clindamycin as last line of treatment for a duration of less than 14 days.
- •Patients refusing to participate
- •Patients under legal protection (guardianship, curatorship, ..)
结局指标
主要结局
Failure of Clindamycine
时间窗: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)
New diagnosis of PJI at the same site, caused by the same microbial agent
次要结局
- Safety of Clindamycin(During the treatment and 6 month after)
- Correlation between failure of Clindamycin and blood level of Clindamycin(within 2 years of the diagnosis (within one year for patients diagnosed in December 2019))
研究者
研究点 (1)
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