Evaluation of Bacterial Infection and Antimicrobial Stewardship in Neonatal Sepsis in Nagpur district, Maharashtra using Nanopore Sequencing (MinION), System:)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Early and accurate detection of pathogen and AMR genotyping towards antimicrobial stewardship in neonatal sepsis
研究概览
简要总结
Title: Evaluation Of Bacterial Infection and Antimicrobial Stewardship In Neonatal Sepsis from Nagpur District, Maharashtra Using Nanopore Sequencing (MinION), System: A Cross-Sectional Observational Study
Population: 100 Indian neonates(<28days)
Intervention: None
Objectives:
1. To evaluate Nanopore sequencing as rapid identification test for detection of bacterial and fungal infection in whole blood of suspected neonatal sepsis cases (age under 28 days) from GMCH, Nagpur
2. To characterize AMR in these samples towards targeted therapy
3. To evaluate cost- effectiveness of the test.
Design/Methodology:
This is a cross-sectional observational study, to detect bacterial and fungal infection in whole blood of 100 suspected neonatal sepsis cases & AMR characterization towards targeted therapy by nanopore sequencing. Whole blood samples (total 3 ml- 2 ml blood for routine culture study and an extra 1 ml of research sampling for the sequencing) will be collected from the newborns admitted on suspicion/diagnosis of sepsis at the Government Medical College & Hospital, Nagpur. The blood sample for research will be collected in the same venipuncture done for routine treatment related investigations. There is no intervention involved in this study, so it does not meet the definition of a clinical trial with study arms.
Total Duration of Study: Six months
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Presenting with clinical suspicion/ diagnosis of sepsis -Seeking care at participating study site i.e. GMCH Nagpur -Parent/legal guardian willing to provide consent for participation, including sample collection.
排除标准
- •Neonates already on antibiotic treatment -Already enrolled in this or other research study/ clinical trial -As per clinician judgement precluding any medical condition.
结局指标
主要结局
Early and accurate detection of pathogen and AMR genotyping towards antimicrobial stewardship in neonatal sepsis
时间窗: End of the study
次要结局
- AMR surveillance by generating crucial data on neonatal sepsis pathogens and resistance patterns in Nagpur, informing local antimicrobial guidelines(End of the study)
- aid policy development and antimicrobial stewardship program (ASP) implementation in NICUs, ensuring judicious antibiotic use, reducing multidrug-resistant infections, and improving neonatal health outcomes.(End of the study)
研究者
Dr Archana Patel
Lata Medical Research Foundation