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

The Chinese University of Hong Kong

Status and phase

Completed

Phase 4

Conditions

Influenza

Lower Respiratory Tract Infection

Treatments

Drug: Macrolide treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01779570

RGC CUHK468112

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.