To Evaluate Mucosal and Systematic Immune Response to Acute Respiratory Tract Infections of South African Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 13
SponsorDesmond Tutu TB Centre
About this trial
The goal of this observational study is to answer a few questions about respiratory tract infections in South African children:
1. 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? 2. The body's immune response (soldier- cells) in blood and saliva (spit) will be studied. 3. What is the short-term effect of COVID-19 and other respiratory viruses/ germs on the breathing (lung function) of children? 4. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Admitted for < 72 hours
Trial population
Children aged 0-13 years will be recruited from Tygerberg Hospital (TBH) in Cape Town, South Africa. TBH serves as regional referral centres to the surrounding health sub-districts (Northern, Tygerberg, Khayelitsha and Eastern) serving over 30% of the metropolitan population (3.5 million residents). TBH also serves as a tertiary-level referral centre for paediatric emergencies, infectious diseases and pulmonology.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Acute RTIs
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
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).2
Targeted protein markers in the saliva and serum of children presenting to Tygerberg Hospital with an acute respiratory tract infection.
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.
Time frame
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).3
The respiratory pathogens identified in children presenting to Tygerberg Hospital with acute respiratory illnesses
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).
Time frame
Nasopharyngeal aspirates will be done at baseline (day of enrolment).Secondary outcomes
1
Severity of respiratory disease in South African children presenting with acute respiratory tract infections to Tygerberg Hospital.
Severity of disease will be determined at presentation and discharge according to the Clinical Respiratory Distress (CRS) score. The CRS uses 6 parameters to obtain a score. These include respiratory rate, auscultation, use of accessory muscles, mental status, room air saturations and colour. Respiratory distress is then classified into mild, moderate or severe. 0-3: Mild distress; 4-6: Moderate distress; ≥7: Severe distress. Data will be captured on CRFs from the time of admission to the time of hospital discharge.
Time frame
Severity of respiratory distress will be quantified at baseline (presentation to hospital) and at discharge (up to 90 days from baseline).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Desmond Tutu TB Centre
Lead sponsor
European Union
Collaborator
Source ClinicalTrials.gov