Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Lower Respiratory Tract Infection |
Drug: Macrolide treatment |
Phase 4 |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2013 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Macrolide treatment
Azithromycin 500 mg daily for 5 days
|
Drug: Macrolide treatment |
|
No Intervention: No macrolide treatment
No azithromycin
|
Detailed Description:
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 2 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- established influenza A or B infection by virologic tests
- age >/=18 years
- present within 4 days from illness onset
- clinical evidence of LRTI and require hospital care
- require antiviral (oseltamivir) treatment
- able to provide written, informed consent.
Exclusion Criteria:
- patients on immunosuppressants
- pregnant or lactating woman
- known hepatic failure, end-stage renal failure, cardiac arrhythmia (e.g. prolonged corrected QT interval >450 msec)
- known contraindications to azithromycin (e.g. allergic reaction)
- lack of consent for study.
Contacts and Locations| Contact: Nelson LS Lee, MD | leelsn@cuhk.edu.hk | |
| Contact: David SC Hui, MD | dschui@cuhk.edu.hk |
| Hong Kong | |
| Prince of Wales Hospital | Not yet recruiting |
| Hong Kong, Hong Kong | |
| Contact: Nelson LS Lee, MD leelsn@cuhk.edu.hk | |
| Contact: David SC Hui, MD dschui@cuhk.edu.hk | |
| Princess Margaret Hospital | Not yet recruiting |
| Hong Kong, Hong Kong | |
| Contact: Owen TY Tsang, MD tyotsang@yahoo.com.hk | |
| Principal Investigator: | Nelson LS Lee, MD | Chinese University of Hong Kong |
More Information
Additional Information:
Publications:
| Responsible Party: | Nelson Lee, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01779570 History of Changes |
| Other Study ID Numbers: | RGC CUHK468112 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
Influenza Macrolide Anti-inflammatory |
Additional relevant MeSH terms:
|
Influenza, Human Respiratory Tract Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases |
Respiratory Tract Diseases Infection Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013