Development of prognostic model for paediatric patients with Gram-negative infections undergoing antibiotic therapy in paediatric ICU
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 271
- 试验地点
- 2
- 主要终点
- A prognostic model will be developed for predicting outcome of pediatric patients with Gram-negative infections
研究概览
简要总结
The prospective observational study will be carried out at the Pediatric intensive care unit of the Department of Pediatrics, Kasturba Hospital, Manipal Karnataka. The study aims to develop a prognostic model for predicting the outcome of patients with Gram-negative infections undergoing antibiotic therapy. the study will include pediatric patients with culture-positive Gram-negative infections undergoing antibiotic therapy for more than 48 hours in the Pediatric ICU. The patients will be followed up till discharge or death. Serum antibiotic levels, estimated for trough and peak levels, and the antibiotic susceptibility profiles will be correlated with clinical outcomes. The patient clinical characteristics and various risk factors for outcome will be identified. Considering serum drug levels, antibiotic susceptibility profiles, and various risk factors identified as prognostic factors, a prognostic model will be developed using logistic regression.
Objectives:
A. To estimate the serum drug levels of antibiotics used for Gram-negative infections in PICU.
B. To correlate antibiotic susceptibility test reports with serum antibiotic levels and clinical outcomes.
C. To develop a prognostic model for paediatric patients with Gram-negative infections undergoing antibiotic therapy in paediatric ICU
Primary outcome:
A prognostic model will be developed for predicting outcome of pediatric patients with Gram-negative infections
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 28.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •The study includes patients admitted to Paediatric ICU with Gram-negative infections, aged between 28 days and 18 years, and patients with a creatinine clearance (ClCr) above 50mL/min and receiving antibiotics Inj.
- •Ceftriaxone and Inj.
- •Amikacin either alone or in combinations for over 48 hours.
排除标准
- •The patients undergoing treatment with extracorporeal membrane oxygenation (ECMO) or renal replacement therapy (RRT).
结局指标
主要结局
A prognostic model will be developed for predicting outcome of pediatric patients with Gram-negative infections
时间窗: 3 years
次要结局
- Estimated serum antibiotic levels and antibiotic susceptibility profiles correlating with clinical outcomes, will help clinicians optimise antibiotic regimens for pediatric patients.(3 years)
研究者
Krishnakumar Athavil
Manipal College of Pharmaceutical Sciences