Actively Recruiting

Age: 0 - 13Years
All Genders
ID06902194

Mucosal Surveillance and Immunology of Respiratory Pathogens in South African Children Post the COVID-19 Pandemic

Led by Desmond Tutu TB Centre · Updated on 2025-03-30

250

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Desmond Tutu TB Centre

Lead Sponsor

E

European Union

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying respiratory tract infections in South African children aged 0 to 13 years to understand how infections like COVID-19 and other respiratory germs cause symptoms and disease severity. They aim to discover new germs and investigate how immune cells in saliva might predict severe illness. The study also looks at the body's immune response in blood and saliva, the short-term effects on lung function, and the impact on children's and families' quality of life. This observational study is conducted at Tygerberg Hospital, which serves a large and diverse community, including areas with high tuberculosis and HIV rates. Children presenting with acute respiratory symptoms at Tygerberg Hospital will be followed while receiving routine care. Researchers will collect additional samples, including blood, mucus via nasopharyngeal aspirates, and saliva at enrolment, during hospital days two and three, and at discharge. These samples will be analyzed for antibodies, inflammatory proteins, and respiratory pathogens using methods like PCR and metagenomic sequencing. The study involves gathering extensive clinical and environmental information through questionnaires, including vaccination history, previous illnesses, and quality of life assessments. Participants will be monitored during their hospital stay, with data collected on symptom severity and treatment received. Laboratory tests will measure antibodies and immune markers in blood and saliva over time. Researchers will also review respiratory pathogens identified from mucus samples. The study ensures privacy and safety, following ethical guidelines and infection control measures. Participation involves no cost to families, and children can withdraw at any time without affecting their care. The total number of participants planned is around 250 to 300 children, with results helping to improve understanding of respiratory infections in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 13Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0-13 years with acute respiratory tract infections presenting to Tygerberg Hospital (TBH) in Cape Town, South Africa, for routine care
Not Eligible

You will not qualify if you...

  • Admitted for less than 72 hours

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at hospital admission

Observational Sampling and Data Collection

Duration - Duration of hospital admission, up to 90 days

Participants with acute respiratory tract infections are observed during hospital admission. Additional samples including blood, mucus, and saliva are collected at enrolment, with further saliva samples collected on the second and third day of admission and at discharge. Routine care data and clinical information are also collected.

1 to 4 visits (in-person) during hospital stay depending on length of admission

Trial Site Locations

Total: 2 locations

1

Desmond Tutu TB Centre, Tygerberg Hospital

Cape Town, Western Cape, South Africa, 7505

Actively Recruiting

2

Desmond Tutu TB Centre

Cape Town, Western Cape, South Africa, 7505

Actively Recruiting

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Research Team

M

Margaret van Niekerk, Masters (Human Nutrition)

M

Michaile Mackriel, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

The socioeconomic impact of the COVID-19 lockdown on families affected by childhood respiratory illnesses in Cape Town, South Africa.

Michaile G Anthony, Graeme Hoddinott, Margaret Van Niekerk...

https://pubmed.ncbi.nlm.nih.gov/38547177