Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections
Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and mortality worldwide. While viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. Macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. In this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. Such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.
Lower Respiratory Tract Infection
Drug: Macrolide treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Viral RNA and culture negativity in serially collected respiratory tract specimens
- time to recovery [ Time Frame: within 10 days post-intervention ] [ Designated as safety issue: No ]e.g. time to symptom resolution, time to hospital discharge, etc
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||June 2015 (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
|Contact: Nelson LS Lee, MDfirstname.lastname@example.org|
|Contact: David SC Hui, MDemail@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Nelson LS Lee, MD firstname.lastname@example.org|
|Contact: David SC Hui, MD email@example.com|
|Princess Margaret Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Owen TY Tsang, MD firstname.lastname@example.org|
|Principal Investigator:||Nelson LS Lee, MD||Chinese University of Hong Kong|