Clinical Presentation and Laboratory Characterization of Respiratory Microbial Colonization and Antimicrobial Resistance Profile in children aged 03-60 months with Acute Respiratory Infections attending OPD at Government Medical College Nagpur, Maharashtra, using Metagenomics Next Generation Sequencing approach: A cross-sectional, observational study.
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
- Identification of respiratory microbiome and AMR profile
研究概览
简要总结
Title: Clinical Presentation and Laboratory of Respiratory Microbial colonization and
Antimicrobial Resistance Profile in children aged 03-60 months with acute Respiratory
Infection Attending OPD at Government Medical college Nagpur, Maharashtra, using
Metagenomics Next Generation Sequence approach: A cross-sectional, observational
study.
**Population:**100 children (03-60 months)
Intervention : None
Objectives:
Aim 1:
To use mNGS technology to analyze nasopharyngeal samples from paediatric population aged 03 to 60 months with ARI, to identify possible etiological cause of ARI and its association with clinical presentations in children attending tertiary care hospital in Nagpur.
Aim2:
To study drug sensitivity profile among pediatric groups to antimicrobial and antivirals for AMR determination and risk assessment
Aim3:
To characterization of the microbial population and their seasonal variations
**Design/Methodology:**This is a cross-sectional, observational, exploratory study design, to study the microbial colonization in nasopharyngeal (NP) swabs using mNGS techniques in children aged 03 to 60 months with ARI attending the pediatric outpatient department at Government Medical College & Hospital, Nagpur. There is no intervention involved in this study, so it does not meet the definition of a clinical trial with study arms.
**Total Study Duration:**6 months
**Subject Participation Duration:**one time, at enrollment
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Month(s) 至 60.00 Month(s)（—）
- 性别
- All
入选标准
- •Presenting with clinical symptoms of acute respiratory infection (ARI) 2) Seeking care at a participating study site i.e. GMCH Nagpur 3)Parent/legal guardian willing to provide consent for participation, including sample collection.
排除标准
- •Prior enrolment in this study 2) Presence of any conditions/ criteria that preclude the participation in the study as per investigator’s judgment 3) Already enrolled in other research study/ clinical trial 4) Consent refusal.
结局指标
主要结局
Identification of respiratory microbiome and AMR profile
时间窗: End of the study
次要结局
- Valuable insights into the epidemiology and etiology of respiratory infections in children.(End of the study)
- Differences in clinical presentation of ARI in children with different possible causative pathogens.(End of study)
- Development of evidence-based policies for the prevention and management of ARI, as well as antimicrobial stewardship strategies. Ultimately, these efforts aim to reduce morbidity and mortality associated with ARI in children across India(End of the study)
研究者
Dr Archana Patel
LATA MEDICAL RESEARCH FOUNDATION