NCT06068673已完成不适用
The Potential Impact of Clindamycin on Neurosurgery Patients.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Neuron-specific enolase (NSE) Blood Concentration
研究概览
简要总结
A prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy to assess its effect on neurological complication in relation to Neuron-specific enolase (NSE) and Neurotensin biomarkers levels.
详细描述
- This is a prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy is prescribed (900 - 1200 mg twice daily) will be recruited from Alexandria University Main Hospital.
- Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA.
- All patients will be assessed for complete blood count (CBC), kidney function, liver function, Methodology
- Patients will be enrolled if they underwent surgery or presented with clinical signs of meningitis.
- All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
- Complete physical, laboratory, and radiological assessment will be done for all patients
- All patients will be followed up during 2 weeks period.
- Serum samples will be collected for measuring the biomarkers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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
Group A
Experimental
Group I are patients who will receive clindamycin added-on therapy.
干预措施: Clindamycin 600 mg (Drug)
Group B
Active Comparator
Group II patients will be managed with the standard regimen.
干预措施: standard regimen (Drug)
结局指标
主要结局
Neuron-specific enolase (NSE) Blood Concentration
时间窗: 2 weeks
Serum Level of NSE pg/ml
Neurotensin Blood Concentration
时间窗: 2 Weeks
Serum Level of Neurotensin pg/ml
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial VaginosisBacterial VaginosisNCT03080740Guangzhou Yipinhong Pharmaceutical CO.,LTD300
已完成
不适用
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain ControlPancreas CancerBiliary Tract CancerNCT02002806Indiana University150
已完成
2 期
Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's DiseaseAlzheimer DiseaseNCT00911807Ever Neuro Pharma GmbH217
撤回
2 期
Minocycline Efficacy in Improving Neurological Outcome of Patients Who Undergo Endovascular Revascularization for Acute Ischemic StrokeAcute Ischemic StrokeNCT05367362State University of New York at Buffalo134
已完成
不适用
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic RhinitisChronic RhinitisNCT04769596Neurent Medical143