Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Microbiological eradication
研究概览
简要总结
This observational study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.
Inclusion Criteria:
Pediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
EVD placement for managing CNS infections.
Exclusion Criteria:
Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
Neonates (less than 1 month old), pregnant, or breastfeeding patients.
Outcome Measures:
Primary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures).
Secondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.
详细描述
Background:
Central nervous system (CNS) bacterial infections, such as meningitis and ventriculitis, are severe conditions in pediatric patients, often resulting from healthcare-associated complications, invasive procedures, or the spread of infection from other body sites. Multi-drug-resistant (MDR) pathogens, particularly carbapenem-resistant Acinetobacter baumannii, pose significant challenges in treating these infections. Standard treatment options, like colistimethate sodium, are associated with limited penetration into the CNS and potential toxicity. This study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.
Data Collection and Analysis:
Patient data, including demographics, clinical presentations, treatment regimens, laboratory findings (CSF analysis, cultures), and adverse effects, will be systematically collected and analyzed. The study will employ appropriate statistical tests to determine the significance of differences between the two groups.
Ethical Considerations:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 1 month to 18 years.
- •Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
- •EVD placement for managing CNS infections.
排除标准
- •Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
- •Neonates (less than 1 month old).
研究组 & 干预措施
Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria
干预措施: Tigecycline (Tygacil) (Drug)
Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria
干预措施: Colistimethate sodium (CMS) (Drug)
结局指标
主要结局
Microbiological eradication
时间窗: follow up of the patients from time of enrollment to end of treatment is for 14-21 days
CSF Culture: Conducted at diagnosis and follow up for it till the end of the treatment course to monitor microbiological clearance. Two consecutive negative cultures are required to consider positive microbiological eradication.
Clinical Cure rate
时间窗: follow up of the patients from time of enrollment to end of treatment is for 14-21 days
Resolution of infection symptoms like fever, seizures, fatigue and neck stiffness.
次要结局
未报告次要终点