Effect of clarithromycin on influenza infection
| ISRCTN | ISRCTN11273879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11273879 |
| Secondary identifying numbers | UW 14-540 |
- Submission date
- 25/01/2015
- Registration date
- 02/02/2015
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Administration Block 808
Queen Mary Hospital
102 Pokfulam Road
Hong Kong
-
Hong Kong
 ORCID ID |
0000-0003-3323-958X |
|---|---|
| Phone | +852 (0)22554049 |
| ivanfn@gmail.com |
Study information
| Study design | Open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effect of clarithromycin on influenza respiratory tract infection: an open-label randomised controlled trial |
| Study objectives | 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(s) | University of Hong Kong/Hospital Authority Hong Kong West Cluster Institutional Review Board, 05/11/2014, UW 14-540 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 04/02/2015 |
| Completion date | 30/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/02/2015 |
| Date of final enrolment | 30/04/2015 |
Locations
Countries of recruitment
- China
- Hong Kong
Study participating centre
Hong Kong
-
China
Sponsor information
University/education
Medical School
Queen Mary Hospital
102 Pokfulam Road
Hong Kong
-
China
| Phone | +852 (0)22554049 |
|---|---|
| ivanfn@gmail.com | |
"ROR" |
https://ror.org/02zhqgq86 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Hong Kong, 香港大學, Universitas Hongkongensis, HKU
- Location
- Hong Kong
Results and Publications
| Intention to publish date | 31/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To publish in an infectious diseases journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference added.
13/07/2018: The primary and secondary outcome measures were updated.
08/02/2016: The recruitment end date has been updated from 31/03/2016 to 30/04/2015.
