Influenza, lower respiratory tract infection Infections and Infestations Influenza, lower respiratory tract infection
Conditions
Interventions
Current interventions as of 16/02/2015:
Study arm: 5-day course of amoxicillin-clavulanate + oseltamivir and a 2-day course of double combination of naproxen and clarithromycin
Sponsors
University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Diagnosed of influenza, lower respiratory tract infection 3. Requiring hospitalisation 4. Willing to comply with the study programme 5. Provided informed consent
Exclusion criteria
Exclusion criteria: 1. Allergic to clarithromycin, amoxicillin-clavulanate, oseltamivir, or naproxen 2. Moderate renal impairment (creatinine clearance < 30 mL/min) 3. Pregnancy 4. Breastfeeding 5. Inability to comprehend and follow all required study procedures 6. Human immunodeficiency virus (HIV) infection 7. Received an experimental agent (vaccine, drug, biological, device, blood product or medication) within 1 month before recruitment or expecting to receive an experimental agent during the study 8. Unwillingness or refusal to participate in another clinical study after the end of this study 9. History of alcohol or drug abuse in the past 5 years 10. Any condition that the investigator believes might interfere with successful completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 13/07/2018: 30-day mortality Previous primary outcome measures: Nasopharyngeal aspirate viral load reduction, measured with polymerase chain reaction from day 0 (baseline) to day 3 after recruitment | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/07/2018: 1. 90-day mortality 2. Serial changes in the nasopharyngeal aspirate (NPA) virus titer 3. Percentage change of neuraminidase-inhibitor-resistant A(H3N2) virus (NIRV) quasispecies measured by means of pyrosequencing 4. Pneumonia severity index (PSI) from days 1 to 4 after antiviral treatment 5. Length of hospitalisation Previous secondary outcome measures: 1. Resolution of fever (from day 0 to day 3) 2. Duration of hospitalisation (from admission to discharge from hospital for that particular admission) 3. Mortality rate (from day of recruitment to 1 month after recruitment) | — |
Countries
Hong Kong
Outcome results
None listed