Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Pediatric nasal microbiome diversity after parent-to-child NMT.
研究概览
简要总结
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
详细描述
This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome following nasal decolonization for S. aureus. Infants admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and infants, eligible infants will undergo an NMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria
- •Child has had a prior nasal surveillance culture grow S. aurues
- •Child is <18 years of age
- •Child completed treatment with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care two or more days before the planned transplant
- •Child has anticipated hospital length of stay >3 days after completing intranasal mupirocin treatment
- •Infant >25 weeks gestation unless >2 months chronological age
排除标准
- •Child is a ward of the State
- •Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
- •Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
- •Inclusion criteria
- •Donor is able to provide informed consent
- •Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)
- •Exclusion criteria
- •Donor had positive COVID-19 test in prior 21 days
- •Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
- •Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)
- •Donor tests positive on baseline screening test for S. aureus nasal colonization.
- •Donor tests positive on baseline screening test for a respiratory pathogen.
- •Donor is not able to provide written informed consent
- •Donor is not able to be present at the bedside at the time of intervention.
- •Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
- •Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.
- •Donor has smoked within the last month
研究组 & 干预措施
Single NMT
Swab parent nares then insert swab directly into child nares once.
干预措施: Nasal Microbiota Transplant (NMT) (Biological)
Placebo
Insert a sterile swab into child nares.
干预措施: Placebo (Biological)
Repeat NMT
Swab parents nares then insert swab directly into child nares multiple times.
干预措施: Nasal Microbiota Transplant (NMT) (Biological)
结局指标
主要结局
Pediatric nasal microbiome diversity after parent-to-child NMT.
时间窗: Day 2, 4, 7, 10, 14 days post-intervention
This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.
次要结局
未报告次要终点