Upper Respiratory Tract InfectionPhase 3NCT00979667
A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection
A Phase 3 study testing Oseltamivir and Zanamivir in people with Upper Respiratory Tract Infection and Influenza, run by Chinese University of Hong Kong at 3 sites in 2 countries.
Trial summary
To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Respiratory Tract Infection, Influenza
- What is being tested?
- Oseltamivir and Zanamivir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years or older with body weight >40kg
- Written informed consent
- Presented within 48 hours of onset of influenza-like illness
- Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:
- Clinical criteria
- Fever >38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
- At least one upper respiratory tract infection (cough, running nose, sore throat)
- Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms
Who cannot join
- Age below 18 years
- Persons who lack the ability to care for themselves
- Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
- Pregnancy or lactation
- Coexisting liver disease
- Coexisting cardiovascular disease except stable hypertension without complication
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- Coexisting chronic pulmonary disease
- Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
- Renal failure
- Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
- Known intolerance to oseltamivir or zanamivir
- Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
- Subjects who have received oseltamivir as prophylaxis for H1N1 infection
- Subjects who have received any investigational drug within 1 month prior to study entry
- Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Hong Kong2 sites
Fanling Family Medicine Centre
Hong Kong
Sai Ying Pun Jockey Club General Outpatient Clinic
Hong Kong
About this study
Official title: Multicentre, Randomized, Controlled Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As The First Line Treatment For Human Swine Influenza (H1N1) Infection In Designated Flu Clinics During The Pandemic Influenza in Hong Kong
To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.
Read the detailed description
The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.
The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.
- Conditions
- Upper Respiratory Tract Infection, Influenza
- Being tested
- Oseltamivir, Zanamivir, Placebo of Oseltamivir
- Keywords
- Upper respiratory tract infection, Influenza A, Human Swine Influenza
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Also called Tamiflu
75 mg twice daily for 5 days
ZanamivirDrug
Also called Relenza
10 mg twice daily for 5 days
Placebo of OseltamivirDrug
Also called Tamiflu Placebo
twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir | Experimental | Not described Receives: Drug: Oseltamivir |
| Zanamivir | Experimental | Not described Receives: Drug: Zanamivir |
| Placebo of Oseltamivir | Placebo comparator | Not described Receives: Drug: Placebo of Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to symptoms resolution as reported by the patient
Measured: one week
Secondary outcomes (3)
Treatment failure including hospitalization due to disease worsening.
Measured: one week
Viral load
Measured: one week
Severity of disease as measured by the patient diary and quality of life using SF12v2.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionOct 2010
Why it stopped: Decreased Influenza activity; thus decrease/no eligible patient to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Chinese 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, Hospital Authority
- Investigators
- Augustine T. LAM, MBBS, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979667
- Sponsor's protocol ID
- CCT2009-CS-6
- Status last verified
- May 2010
- First submitted
- 17 Sep 2009
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Controlled Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As The First Line Treatment For Human Swine Influenza (H1N1) Infection In Designated Flu Clinics During The Pandemic Influenza in Hong Kong
- ClinicalTrials.gov ID
- NCT00979667
- Acronym / sponsor ID
- CCT2009-CS-6
- Conditions
- Upper Respiratory Tract Infection, Influenza
- Keywords
- Upper respiratory tract infection, Influenza A, Human Swine Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decreased Influenza activity; thus decrease/no eligible patient to recruit
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, Hospital Authority
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- 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.
To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.
Detailed description
The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.
The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir | Experimental | Drug: Oseltamivir |
| Zanamivir | Experimental | Drug: Zanamivir |
| Placebo of Oseltamivir | Placebo comparator | Drug: Placebo of Oseltamivir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients 18 years or older with body weight >40kg
- Written informed consent
- Presented within 48 hours of onset of influenza-like illness
- Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:
Key exclusion criteria (15 listed)
- Age below 18 years
- Persons who lack the ability to care for themselves
- Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
- Pregnancy or lactation
- Coexisting liver disease
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 |
|---|---|---|
| OseltamivirAlso: Tamiflu75 mg twice daily for 5 days | Drug | Oseltamivir |
| ZanamivirAlso: Relenza10 mg twice daily for 5 days | Drug | Zanamivir |
| Placebo of OseltamivirAlso: Tamiflu Placebotwice daily for 5 days | Drug | Placebo of Oseltamivir |
Primary outcome
Time to symptoms resolution as reported by the patient
Time frame: one week
3 secondary outcomes
Treatment failure including hospitalization due to disease worsening.
Time frame: one week
Viral load
Time frame: one week
Severity of disease as measured by the patient diary and quality of life using SF12v2.
Time frame: one week
Results and safety
The study was stopped early (reason given: Decreased Influenza activity; thus decrease/no eligible patient to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
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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.
Augustine T. LAM, MBBS principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oseltamivir and Zanamivir in people with Upper Respiratory Tract Infection and Influenza, run by Chinese University of Hong Kong at 3 sites in 2 countries.
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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong, China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decreased Influenza activity; thus decrease/no eligible patient to recruit). 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 to symptoms resolution as reported by the patient (time frame: one week). 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 11 Apr 2011.