Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Anti-Inflammatory Agents

Criteria

Inclusion Criteria:

1. established influenza A or B infection by virologic tests

2. age >/=18 years

3. present within 4 days from illness onset

4. clinical evidence of LRTI and require hospital care

5. require antiviral (oseltamivir) treatment

6. able to provide written, informed consent.

Exclusion Criteria:

1. patients on immunosuppressants

2. pregnant or lactating woman

3. known hepatic failure, end-stage renal failure, cardiac arrhythmia (e.g. prolonged corrected QT interval >450 msec)

4. known contraindications to azithromycin (e.g. allergic reaction)

5. lack of consent for study.