Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05279534
Eligibility Criteria:
Inclusion Criteria:
* Male and female children, 6 months to 5 years-old
* Diagnosed with upper respiratory tract infection with pharyngitis and/or tonsillitis by a physician
* With fever \>37.5 Celsius degrees and FLACC (Face, Legs, Activity, Cry and Consolability) score \>3
* Symptom onset no more than 48h before study entry
* Body weight at birth \>2500 gr
* Informed consent provided by parents or legal guardians
Exclusion Criteria:
* Failure to thrive
* Asthma or significant allergic disease
* Use of antibiotics, antivirals, probiotics or prebiotics for more than 48h within 2 weeks of study entry
* History of recurrent respiratory infections (\>2 otitis, \>1 severe sinusitis or \>1 pneumonia) within 12 months of study entry
* History of 2 or more invasive infections (meningitis, cellulitis, osteomyelitis, sepsis)
* Chronic diarrhea or short bowel syndrome
* Congenital heart or respiratory deficiency
* Known alpha1-antitrypsin deficiency
* Concurrent participation in other clinical trial(s)
* Other particular conditions which, in the judgment of the Principal Investigator, may interfere with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT05279534
Study Brief:
Protocol Section:
NCT05279534