Status:
UNKNOWN
Flufenamic Acid for Hospitalised Influenza Infection
Lead Sponsor:
The University of Hong Kong
Conditions:
Influenza A
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It is well recognized that respiratory viruses cause substantial disease burden every year. Among all known respiratory viruses, influenza virus is the greatest cause of disability-adjusted life years...
Detailed Description
This double blind randomized-controlled trial will assess the clinical efficacy, mortality reduction and viral load reduction of clarithromycin and FFA in patients hospitalized for pneumonia secondary...
Eligibility Criteria
Inclusion
- Recruited subjects include all adult patients ≥18 years hospitalised for virologically confirmed influenza infection.
- 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
- Symptom duration ≤72 hours
- Radiological changes of pulmonary infiltrate by chest radiography or computerised tomography
- 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
- Inability to comprehend and to follow all required study procedures.
- Allergy or severe reactions including renal or hepatic dysfunctions to clarithromycin, FFA, oseltamivir, amoxicillin-clavulanate or esomeprazole will be excluded
- Patient with moderate renal impairment (creatinine clearance \<30mL/min)
- Prolonged QT or ventricular cardiac arrhythmias, including torsade de pointes.
- Patient with a history of cholestatic jaundice and/or liver dysfunction associated with prior clarithromycin use
- Patient on cisapride, pimozide, astemizole, terfenadine, ergotamine, dihyroergotamine, or statins medications which could not be stopped
- Patient on colchicine with renal or hepatic impairment.
- Pregnant or lactating women
- Inability to comprehend and to follow all required study procedures
- Have known human immunodeficiency virus infection
- 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.
- 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.
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03238612
Start Date
January 8 2018
End Date
October 31 2020
Last Update
October 22 2019
Active Locations (1)
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1
Ivan Hung
Hong Kong, Hong Kong