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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT03238612
Eligibility Criteria:
Inclusion Criteria:
1. Recruited subjects include all adult patients ≥18 years hospitalised for virologically confirmed influenza infection.
2. Auditory temperature ≥38°C with at least one of the following symptoms (cough, sputum production, sore-throat, nasal discharge, myalgia, headache or fatigue) upon admission
3. Symptom duration ≤72 hours
4. Radiological changes of pulmonary infiltrate by chest radiography or computerised tomography
5. All subjects give written informed consent. Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterise immune response.
Exclusion Criteria:
1. Inability to comprehend and to follow all required study procedures.
2. Allergy or severe reactions including renal or hepatic dysfunctions to clarithromycin, FFA, oseltamivir, amoxicillin-clavulanate or esomeprazole will be excluded
3. Patient with moderate renal impairment (creatinine clearance \<30mL/min)
4. Prolonged QT or ventricular cardiac arrhythmias, including torsade de pointes.
5. Patient with a history of cholestatic jaundice and/or liver dysfunction associated with prior clarithromycin use
6. Patient on cisapride, pimozide, astemizole, terfenadine, ergotamine, dihyroergotamine, or statins medications which could not be stopped
7. Patient on colchicine with renal or hepatic impairment.
8. Pregnant or lactating women
9. Inability to comprehend and to follow all required study procedures
10. Have known human immunodeficiency virus infection
11. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
12. Have a history of alcohol or drug abuse in the last 5 years. Have any condition that the investigator believes may interfere with successful completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03238612
Study Brief:
Protocol Section:
NCT03238612