Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections
|ClinicalTrials.gov Identifier: NCT01779570|
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : July 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza Lower Respiratory Tract Infection||Drug: Macrolide treatment||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections|
|Study Start Date :||February 2013|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
Experimental: Macrolide treatment
Azithromycin 500 mg daily for 5 days
|Drug: Macrolide treatment|
No Intervention: No macrolide treatment
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|