Plain English Summary
Background and study aims
Influenza viruses cause substantial disease burden every year. Patients are frequently hospitalised for pneumonia secondary to influenza infection. Clarithromycin and naproxen inhibit seasonal influenza virus infection in human airway epithelial cells with additional anti-inflammatory effects. The aim in this study is to assess the effects of clarithromycin and naproxen in patients diagnosed with pneumonia secondary to respiratory viral infection.
Who can participate?
Adult patients, hospitalised in Queen Mary Hospital, Hong Kong (China) for pneumonia
What does the study involve?
Patients will be randomly assigned to a 5-day course of amoxicillin-clavulanate and oseltamivir and a 2-day course of double combination of naproxen and clarithromycin (study arm) or a 5-day course of amoxicillin-clavulanate and oseltamivir (control group).
What are the possible benefits and risks of participating?
Possible benefits include reduction in mortality, shortened hospital stay, faster fever resolution and viral load reduction. Risks not provided at time of registration
Where is the study run from?
Queen Mary Hospital, Hong Kong (China)
When is the study starting and how long is it expected to run for?
February 2015 to April 2016
Who is funding the study?
University of Hong Kong (China)
Who is the main contact?
Dr Ivan Hung
ivanfn@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ivan Hung
ORCID ID
http://orcid.org/0000-0003-3323-958X
Contact details
Administration Block 808
Queen Mary Hospital
102 Pokfulam Road
Hong Kong
-
Hong Kong
+852-22554049
ivanfn@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UW 14-540
Study information
Scientific title
Effect of clarithromycin on influenza respiratory tract infection: an open-label randomised controlled trial
Acronym
Study hypothesis
A combination of clarithromycin, oseltamivir and naproxen will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with influenza respiratory tract infection compared with oseltamivir alone.
Ethics approval
University of Hong Kong/Hospital Authority Hong Kong West Cluster Institutional Review Board, 05/11/2014, UW 14-540
Study design
Open-label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Influenza, lower respiratory tract infection
Intervention
Current interventions as of 16/02/2015:
Study arm: 5-day course of amoxicillin-clavulanate + oseltamivir and a 2-day course of double combination of naproxen and clarithromycin
Control arm: 5-day course of amoxicillin-clavulanate + oseltamivir
Previous interventions:
1. Study arm: 2-day course of oseltamivir + clarithromycin + naproxen + 7-day course of amoxicillin-clavulanate
2. Control arm: 2-day course of oseltamivir + 7-day course of amoxicillin-clavulanate
Intervention type
Drug
Phase
Phase IV
Drug names
1. Oseltamivir
2. Clarithromycin
3. Naproxen
4. Amoxicillin-clavulanate
Primary outcome measures
Nasopharyngeal aspirate viral load reduction, measured with polymerase chain reaction from day 0 (baseline) to day 3 after recruitment
Secondary outcome measures
1. Resolution of fever (from day 0 to day 3)
2. Duration of hospitalisation (from admission to discharge from hospital for that particular admission)
3. Mortality rate (from day of recruitment to 1 month after recruitment)
Overall trial start date
04/02/2015
Overall trial end date
30/04/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥ 18 years
2. Diagnosed of influenza, lower respiratory tract infection
3. Requiring hospitalisation
4. Willing to comply with the study programme
5. Provided informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Allergic to clarithromycin, amoxicillin-clavulanate, oseltamivir, or naproxen
2. Moderate renal impairment (creatinine clearance < 30 mL/min)
3. Pregnancy
4. Breastfeeding
5. Inability to comprehend and follow all required study procedures
6. Human immunodeficiency virus (HIV) infection
7. Received an experimental agent (vaccine, drug, biological, device, blood product or medication) within 1 month before recruitment or expecting to receive an experimental agent during the study
8. Unwillingness or refusal to participate in another clinical study after the end of this study
9. History of alcohol or drug abuse in the past 5 years
10. Any condition that the investigator believes might interfere with successful completion of the study
Recruitment start date
18/02/2015
Recruitment end date
30/04/2015
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Queen Mary Hospital
102 Pokfulam Road
Hong Kong
-
China
Sponsor information
Organisation
University of Hong Kong
Sponsor details
Medical School
Queen Mary Hospital
102 Pokfulam Road
Hong Kong
-
China
+852-22554049
ivanfn@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Hong Kong (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To publish in an infectious diseases journal
Intention to publish date
31/07/2016
Participant level data
Stored in repository
Results - basic reporting
Publication summary