Mucosal Surveillance and Immunology of Respiratory Pathogens in South African Children Post the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Poly-reactive and pathogen-specific antibodies in the saliva and serum of South African children presenting with an acute respiratory tract infection to Tygerberg Hospital.
研究概览
简要总结
The goal of this observational study is to answer a few questions about respiratory tract infections in South African children:
- How do children with COVID-19 and other respiratory (chest, throat, ear or nose) germs show symptoms? What signs should be looked for, and which children are more likely to get seriously ill? Are there any new germs that haven't been discovered yet? Can immune cells in saliva predict which children will get more severe disease?
- The body's immune response (soldier- cells) in blood and saliva (spit) will be studied.
- What is the short-term effect of COVID-19 and other respiratory viruses/ germs on the breathing (lung function) of children?
- What is the impact of respiratory germs on the quality of life in children and their families? The investigators aim to recruit a minimum of 250 children with respiratory pathogens.
详细描述
This observational cohort study will include children aged 0-13 years with acute respiratory tract infections who present to Tygerberg Hospital (TBH) for routine care. Key routine care data, including vaccination history, detailed medical history, and treatments received during hospital admission (such as oxygen therapy, antiviral medication, antibiotics, or other supportive drugs), will be documented in case report forms (CRFs).
South Africa has a high burden of tuberculosis and HIV infection, and it is important to study respiratory tract infections in this population.
Children aged 0-13 years will be recruited from Tygerberg Hospital (TBH), which functions as a regional referral center for the surrounding health sub-districts, including Northern, Tygerberg, Khayelitsha, and Eastern, collectively serving over 30% of the metropolitan population (3.5 million residents). Additionally, TBH acts as a tertiary-level referral center for paediatric emergencies, infectious diseases, and pulmonology.
Children with acute respiratory symptoms who present to TBH will be enroled in the study, provided they have been hospitalised for less than 72 hours, consent has been obtained from both the caregiver and child (where applicable), and there are no medical contraindications to collecting respiratory samples.
This study will be implemented within routine care services and clinical and laboratory data collected for routine care will be used for research. The research team will collect additional data and samples.
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
- — 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0-13 years with acute respiratory tract infections presenting to Tygerberg Hospital (TBH) in Cape Town, South Africa, for routine care
排除标准
- •Admitted for < 72 hours
结局指标
主要结局
Poly-reactive and pathogen-specific antibodies in the saliva and serum of South African children presenting with an acute respiratory tract infection to Tygerberg Hospital.
时间窗: Antibodies will be measured at baseline (enrolment) in saliva and serum and in saliva on the second and third day of admission and on the day of discharge (up to 90 days from baseline).
Total antibodies to specific respiratory pathogens, as well as poly-reactive antibodies (IgG, IgA and IgM), will be measured in serum and saliva at the time of presentation to hospital. In addition, antibodies will be measured in saliva on days 2 and 3 of admission and on the day of discharge up to 90 days from baseline. The percentage of polyreactive antibodies to pathogen-specific antibodies will be calculated.
Targeted protein markers in the saliva and serum of children presenting to Tygerberg Hospital with an acute respiratory tract infection.
时间窗: Inflammatory protein markers will be measured in saliva and serum at baseline, with additional saliva measurements on days 2 and 3 of admission and on the day of discharge (up to 90 days).
Protein markers in saliva and serum will be measured using a Luminex based Multiplex Immuno-Assay (MIA). Inflammatory markers that will be measured include: CCL19, CCL20, CCL28, CXCL11, CCL11, HGF, CXCL5, CXCL6, IFN-y, TNF-a, MMP2, MPO, Procalcitonin, CRP, and IL-6. All markers will be measured in ug/ml.
The respiratory pathogens identified in children presenting to Tygerberg Hospital with acute respiratory illnesses
时间窗: Nasopharyngeal aspirates will be done at baseline (day of enrolment).
Nasopharyngeal aspirates will be done on all children at enrolment. The Allplex™ RV Essential Assay and a COVID PCR will be done on the NPA samples. The RV 7 tests for 7 viruses: Adenovirus (AdV), Influenza A virus (Flu A), Influenza B virus (Flu B), Metapneumovirus (MPV), Parainfluenza virus (PIV), Respiratory syncytial virus (RSV), Human rhinovirus A/B/C (HRV).
次要结局
- Severity of respiratory disease in South African children presenting with acute respiratory tract infections to Tygerberg Hospital.(Severity of respiratory distress will be quantified at baseline (presentation to hospital) and at discharge (up to 90 days from baseline).)