Status:
COMPLETED
Studying Respiratory Infections and Colonisation in Children Using Daily Minimally-invasive Nasal Sampling
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Spaarne Gasthuis
Conditions:
Respiratory Tract; Infection, Upper (Acute)
Colonization, Asymptomatic
Eligibility:
All Genders
1-5 years
Brief Summary
Rationale: Respiratory tract infections (RTI) are a major cause of morbidity in young children in high- income countries and the major cause of mortality in developing countries. Causative bacteria an...
Eligibility Criteria
Inclusion
- Written informed consent obtained from all legal representatives, for example both parents.
- Child aged 1-5 years of age attending day care, peuterspeelzaal or school at least 2 (half) days a week.
- Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples. This does not include donation of saliva by parents themselves, which is related to a secondary endpoint.
Exclusion
- History of respiratory tract infections requiring hospitalization
- Current use of antibiotics, or antibiotics use in past four weeks
- Use of immune-altering medication (such as steroids, including inhaled corticosteroid)
- No history of severe concomitant disease (severe congenital heart disease, bronchopulmonary dysplasia, prematurity \<32 weeks, cystic fibrosis, sickle cell disease, congenital or acquired immunodeficiency disorders, cardiovascular disease, neuromuscular disorders, oncology patients or major congenital anomalies)
Key Trial Info
Start Date :
January 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06049537
Start Date
January 21 2022
End Date
November 27 2023
Last Update
December 12 2023
Active Locations (1)
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1
Spaarne Gasthuis
Hoofddorp, Netherlands