ISRCTN - ISRCTN11273879: Effect of clarithromycin on influenza infection

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 (0)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

Not available in web format, please use the contact details to request a 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 measure

Current primary outcome measures as of 13/07/2018:
30-day mortality

Previous 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

Current secondary outcome measures as of 13/07/2018:
1. 90-day mortality
2. Serial changes in the nasopharyngeal aspirate (NPA) virus titer
3. Percentage change of neuraminidase-inhibitor-resistant A(H3N2) virus (NIRV) quasispecies measured by means of pyrosequencing
4. Pneumonia severity index (PSI) from days 1 to 4 after antiviral treatment
5. Length of hospitalisation

Previous 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 (if study stopped)

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 type

University/education

Website

Funders

Funder type