Influenza, HumanPhase 4NCT03824847
Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community
A Phase 4 study testing Clarithromycin 250 MG in people with Influenza, Human, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators propose a double-blind randomised placebo-controlled study in naturally occurring influenza virus infections in the community setting to compare the impact of a short course of clarithromycin versus placebo, on the clinical course, viral shedding, immunomodulation, and the antimicrobial resistance… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Clarithromycin 250 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2023to 1 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged between 18-60
- Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) to university health clinics within 48 hours of illness onset.
Who cannot join
- Allergy to clarithromycin or any other macrolides or the ingredients in the tablets, which include microcrystalline cellulose, croscarmelose sodium, magnesium stearate and povidon will be excluded.
- Patients with a history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication, or any underlying immunocompromised condition or receiving immunosuppressive agents will also be excluded.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Public Health, The University of Hong Kong
Hong Kong
About this study
The investigators propose a double-blind randomised placebo-controlled study in naturally occurring influenza virus infections in the community setting to compare the impact of a short course of clarithromycin versus placebo, on the clinical course, viral shedding, immunomodulation, and the antimicrobial resistance pattern of respiratory bacterial carriage of the patients.
Read the detailed description
Background: Influenza continues to pose an imminent threat to public health through seasonal epidemics and occasion pandemics with significant impact on morbidity and mortality. Increasing attention has also been paid in recent years to the potential benefit of immunomodulatory effect of macrolide antibiotics in the management of influenza virus infection.
Aims: To study the immunomodulatory effects of a short course of clarithromycin in naturally occurring influenza virus infection.
Design and subjects: The study is a double-blind, randomised controlled trial. One hundred adults aged 18-60 years will be recruited when they present with symptoms of acute respiratory infection within 48 hours of symptoms onset to university health clinics, and being tested positive with a QuickVue/Sofia (Quidel Corp., San Diego, CA) rapid influenza test. Consented patients tested positive with the rapid test will receive their clinical consultation and prescriptions as indicated as usual, and being randomised to receive either clarithromycin (250mg) or placebo (in a ratio of 1:1) taken twice daily orally for three days. Blood specimen, nasal and throat swabs will be collected on the same day (day 1). They will be followed-up on day 4, day 7 and day 10 for further collection of nasal and throat swabs, and serum samples. A symptom diary will be kept by each participant for 10 days for monitoring the clinical course of the infection.
Study instruments: QuickVue/Sofia (Quidel Corp., San Diego, CA) rapid influenza test, symptom diary, blood specimen, nasal and throat swabs.
Interventions: Intervention group: clarithromycin; placebo group: placebo in identical packaging.
Main outcome measures: The primary outcomes of the study will compare the duration of illness, viral shedding, patterns of plasma cytokine/chemokine and antimicrobial resistance pattern of respiratory bacterial carriage between patients who were randomised to clarithromycin or placebo.
Analysis: Intention to treat.
Potential significance: This will be the first placebo-controlled RCT to investigate the immunomodulatory effect of macrolide antibiotics in the management of influenza virus infection, in terms of its impact on the duration of illness, viral shedding, patterns of plasma cytokine/chemokine and antimicrobial resistance pattern of respiratory bacterial carriage. Findings from this study will have important contribution to our understanding on the potential immunomodulatory effect of macrolides, and help to inform the appropriate clinical management approach, and the potential
- Conditions
- Influenza, Human
- Being tested
- Clarithromycin 250 MG, Placebos
- Keywords
- Macrolides, Immunomodulation
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin 250 MGDrug
Clarithromycin 1 tablet (250mg) twice daily for three days
PlacebosDrug
Placebo group: (identical-looking) placebo 1 tablet twice daily for three days
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Intervention group: clarithromycin 1 tablet (250mg) twice daily for three days Receives: Drug: Clarithromycin 250 MG |
| Placebo group | Placebo comparator | Placebo group: (identical-looking) placebo 1 tablet twice daily for three days. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from recruitment to cessation of clinical illness
Defined as the time when all relevant clinical symptoms are resolved.
Measured: 10 days
Time from recruitment to cessation of viral shedding
Defined as the time when no virus is detected by RT-PCR from both nasal and throat swabs.
Measured: 10 days
Secondary outcomes (6)
Duration and severity of individual symptoms
Participants will keep symptom diary twice daily for 10 days (from D1-D10), using 4-point scale of 0, 1, 2, or 3 for absent, mild, moderate, or severe symptoms respectively. Mild symptoms are easily tolerated and do not interfere with any usual activities; moderate symptoms interfere with usual activities; Severe symptoms are such that the individual cannot carry out usual activities. Ten common influenza symptoms (including feverishness, chills, cough, rhinorrhea, sore throat, general fatigue, headache, myalgia/arthralgia, vomiting, and diarrhea) will be recorded for ten days (D1-D10) and the duration of individual symptoms will be assessed.
Measured: 10 days
Incidence of secondary complications
The symptom diary will be checked on each follow-up (D4, D7, and D10) and collected on D10 by our research staff when the patient returns for follow-up. Symptoms of possible side effects related to treatment (including skin rashes, nausea, vomiting, jaundice, dark urine) will be recorded. The occurrence of any complications including otitis media, bronchitis, sinusitis, and pneumonia will be enquired during all follow-up sessions and recorded, and cross checking with the attending doctor will be done where necessary.
Measured: 28 days
Health-related quality of life
A simple quality of life (QOL) assessment based on two simple validated 11- point visual analog scales will also be done daily by all participants form D1 - D10, one to rate their own ability for performing normal daily activities (0 = unable to perform normal activity to 10 = fully able to perform normal activity) , and the other for a self-perceived overall health status over a 24-hour (0 = worst health to 10 = best possible health), both of which will be compared to an initial assessment of their normal pre-influenza state reported on the D1 baseline. All participants will also be required to complete the Acute Form of the Short Form-36, version 2 (SF-36), in D1, D10 and D28, for a more details assessment on the changes of Health-related quality of life (HRQL) related to the episode of the influenza infection.
Measured: 28 days
Geometric mean rise in antibody titre against the infecting type or subtype of influenza virus
Paired sera will be collected on D1 and D28 for measuring the humoral antibody titres against the infecting type or subtype and other circulating strains of influenza viruses, and for evaluating the geometric mean titer rise from baseline to convalescence.
Measured: 28 days
Changes in blood immunity (Cytokine/chemokine and pro-inflammatory mediators)
Plasma concentrations of 20+ cytokines/chemokines and proinflammatory mediators (e.g. IL-6, IL-8, TNFα, IFN-γ, IL-12p70 etc.) will be measured in each collected blood sample using cytokines bead assay by Flow cytometry.
Measured: 7 days
Change in the carriage rate of common respiratory bacterial pathogen
change in the carriage rate of five common respiratory bacterial pathogen and the proportion of each that were macrolide resistant.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Jun 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Why it stopped: Community recruitment suspended due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dennis Kai-Ming Ip, The University of Hong Kong
- Investigators
- Dennis KM Ip, MD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824847
- Sponsor's protocol ID
- DKMI010.1
- Status last verified
- Nov 2022
- First submitted
- 29 Jan 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community
- ClinicalTrials.gov ID
- NCT03824847
- Acronym / sponsor ID
- DKMI010.1
- Conditions
- Influenza, Human
- Keywords
- Macrolides, Immunomodulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Community recruitment suspended due to COVID-19
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a double-blind randomised placebo-controlled study in naturally occurring influenza virus infections in the community setting to compare the impact of a short course of clarithromycin versus placebo, on the clinical course, viral shedding, immunomodulation, and the antimicrobial resistance pattern of respiratory bacterial carriage of the patients.
Detailed description
Background: Influenza continues to pose an imminent threat to public health through seasonal epidemics and occasion pandemics with significant impact on morbidity and mortality. Increasing attention has also been paid in recent years to the potential benefit of immunomodulatory effect of macrolide antibiotics in the management of influenza virus infection.
Aims: To study the immunomodulatory effects of a short course of clarithromycin in naturally occurring influenza virus infection.
Design and subjects: The study is a double-blind, randomised controlled trial. One hundred adults aged 18-60 years will be recruited when they present with symptoms of acute respiratory infection within 48 hours of symptoms onset to university health clinics, and being tested positive with a QuickVue/Sofia (Quidel Corp., San Diego, CA) rapid influenza test. Consented patients tested positive with the rapid test will receive their clinical consultation and prescriptions as indicated as usual, and being randomised to receive either clarithromycin (250mg) or placebo (in a ratio of 1:1) taken twice daily orally for three days. Blood specimen, nasal and throat swabs will be collected on the same day (day 1). They will be followed-up on day 4, day 7 and day 10 for further collection of nasal and throat swabs, and serum samples. A symptom diary will be kept by each participant for 10 days for monitoring the clinical course of the infection.
Study instruments: QuickVue/Sofia (Quidel Corp., San Diego, CA) rapid influenza test, symptom diary, blood specimen, nasal and throat swabs.
Interventions: Intervention group: clarithromycin; placebo group: placebo in identical packaging.
Main outcome measures: The primary outcomes of the study will compare the duration of illness, viral shedding, patterns of plasma cytokine/chemokine and antimicrobial resistance pattern of respiratory bacterial carriage between patients who were randomised to clarithromycin or placebo.
Analysis: Intention to treat.
Potential significance: This will be the first placebo-controlled RCT to investigate the immunomodulatory effect of macrolide antibiotics in the management of influenza virus infection, in terms of its impact on the duration of illness, viral shedding, patterns of plasma cytokine/chemokine and antimicrobial resistance pattern of respiratory bacterial carriage. Findings from this study will have important contribution to our understanding on the potential immunomodulatory effect of macrolides, and help to inform the appropriate clinical management approach, and the potential
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Clarithromycin 250 MGIntervention group: clarithromycin 1 tablet (250mg) twice daily for three days |
| Placebo group | Placebo comparator | Drug: PlacebosPlacebo group: (identical-looking) placebo 1 tablet twice daily for three days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged between 18-60
- Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) to university health clinics within 48 hours of illness onset.
Key exclusion criteria (2 listed)
- Allergy to clarithromycin or any other macrolides or the ingredients in the tablets, which include microcrystalline cellulose, croscarmelose sodium, magnesium stearate and povidon will be excluded.
- Patients with a history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication, or any underlying immunocompromised condition or receiving immunosuppressive agents will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarithromycin 250 MGClarithromycin 1 tablet (250mg) twice daily for three days | Drug | Intervention group |
| PlacebosPlacebo group: (identical-looking) placebo 1 tablet twice daily for three days | Drug | Placebo group |
Primary outcome
Time from recruitment to cessation of clinical illness
Time frame: 10 days
Defined as the time when all relevant clinical symptoms are resolved.
Time from recruitment to cessation of viral shedding
Time frame: 10 days
Defined as the time when no virus is detected by RT-PCR from both nasal and throat swabs.
6 secondary outcomes
Duration and severity of individual symptoms
Time frame: 10 days
Incidence of secondary complications
Time frame: 28 days
Health-related quality of life
Time frame: 28 days
Geometric mean rise in antibody titre against the infecting type or subtype of influenza virus
Time frame: 28 days
Changes in blood immunity (Cytokine/chemokine and pro-inflammatory mediators)
Time frame: 7 days
Change in the carriage rate of common respiratory bacterial pathogen
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis KM Ip, MD principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clarithromycin 250 MG in people with Influenza, Human, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from recruitment to cessation of clinical illness (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.