Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections
|Influenza Lower Respiratory Tract Infection||Drug: Macrolide treatment||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections|
- cytokine and inflammatory responses [ Time Frame: within 10 days post-intervention ]Serial measurements of selected cytokines/chemokines (e.g. interleukin-6, CXCL8) and proinflammatory molecules (e.g. DAMPs)
- viral clearance [ Time Frame: within 10 days post-intervention ]Viral RNA and culture negativity in serially collected respiratory tract specimens
- time to recovery [ Time Frame: within 10 days post-intervention ]e.g. time to symptom resolution, time to hospital discharge, etc
|Study Start Date:||February 2013|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Macrolide treatment
Azithromycin 500 mg daily for 5 days
|Drug: Macrolide treatment|
No Intervention: No macrolide treatment
Objectives: (1) We aim to investigate the anti-inflammatory effects of macrolide treatment in patients with influenza LRTI and the impact on viral clearance. (2) To investigate the impact of macrolide treatment on influenza symptom and disease resolution.
Design: A randomized, open-label, multicenter study.
Settings: Acute medical facilities in 3 general public hospitals in Hong Kong.
Subjects, Sampling and Intervention: Adult (>/=18 years) patients hospitalized for virologically confirmed influenza LRTI who fulfill the inclusion/exclusion criteria will be randomized to receive (1) azithromycin 500 mg p.o. for 5 days (in addition to antiviral, as part of usual care), or (2) no azithromycin (ie, antiviral alone, part of usual care) after informed consent. Serial blood samples will be collected for cytokine/inflammatory response assays. Serial nasopharyngeal swabs will be collected to assess for viral clearance. Symptoms, clinical progress, radiography and adverse events will be monitored.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779570
|Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Princess Margaret Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Nelson LS Lee, MD||Chinese University of Hong Kong|