To Evaluate Mucosal and Systematic Immune Response to Acute Respiratory Tract Infections of South African Children

NCT06902194 | Recruiting

• 2 other identifiers: N24/08/097-ID31271VERDI (101045989)
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to answer a few questions about respiratory tract infections in South African children:

1. 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. 2.The body's immune response (soldier- cells) in blood and saliva (spit) will be studied.
3. 3.What is the short-term effect of COVID-19 and other respiratory viruses/ germs on the breathing (lung function) of children?
4. 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.

Conditions

Respiratory Tract Infections (RTI); Mucosal Immunity

Keywords

Mucosal immunity; Mucosal immunology; Respiratory tract infections; Saliva

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

• 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.

  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).

• 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).

  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 respiratory distress will be quantified at baseline (presentation to hospital) and at discharge (up to 90 days from baseline).

Study Arms (1)

Acute RTIs

Children aged 0-13 years presenting with acute respiratory tract infections to Tygerberg Hospital.

Eligibility Criteria

• Age: Up to 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \- Children aged 0-13 years with acute respiratory tract infections presenting to Tygerberg Hospital (TBH) in Cape Town, South Africa, for routine care

You may not qualify if:

• Admitted for \< 72 hours

Sponsors & Collaborators

• Desmond Tutu TB Centre: lead
• European Union: collaborator

Study Sites (2)

Desmond Tutu TB Centre, Tygerberg Hospital

Cape Town, Western Cape, 7505, South Africa

RECRUITING

Desmond Tutu TB Centre

Cape Town, Western Cape, 7505, South Africa

RECRUITING

Related Publications (2)

• Anthony MG, Hoddinott G, Van Niekerk M, Dewandel I, McKenzie C, Bekker C, Rabie H, Redfern A, van der Zalm MM. The socioeconomic impact of the COVID-19 lockdown on families affected by childhood respiratory illnesses in Cape Town, South Africa. PLOS Glob Public Health. 2024 Mar 28;4(3):e0003020. doi: 10.1371/journal.pgph.0003020. eCollection 2024.

  PMID: 38547177 BACKGROUND

• Bekker C, Dewandel I, Redfern A, McKenzie C, Lishman J, Verhagen LM, Claassen M, Wilson S, Dunbar R, Bosch C, van Zyl G, Preiser W, Goussard P, Rabie H, van der Zalm MM. Clinical spectrum of disease and outcomes in children with Omicron SARS-COV-2 infection in Cape Town, South Africa. IJTLD Open. 2024 Jan 1;1(1):27-33. doi: 10.5588/ijtldopen.23.0053. eCollection 2024 Jan.

  PMID: 38919411 BACKGROUND

Related Links

• VERDI is a project that prioritises pregnant women, children and high-risk populations in research on new SARS-CoV-2 variants of concern. It also focuses on preparedness for future infections outbreaks, building on experiences with COVID-19 and mpox.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and paxgene samples, as well as saliva and nasopharyngeal aspirate specimens will be collected and stored.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Marieke van der Zalm, PhD

  Desmond Tutu TB Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret van Niekerk, Masters (Human Nutrition)

CONTACT

+27219389177; mbunting@sun.ac.za

Michaile Mackriel, PhD

CONTACT

+27219389177; manthony@sun.ac.za

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: March 30, 2025
• Study Start: October 23, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-02

Locations

ZA (2)