InfluenzaPhase 2NCT00298233
High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza
A Phase 2 study testing Oseltamivir in people with Influenza and Avian Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 3 countries.
Trial summary
Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Influenza, Avian Influenza, Severe Influenza
- What is being tested?
- Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Feb 2006to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least one of the following respiratory symptoms: cough, dyspnea, sore throat
- Evidence of severe influenza or avian influenza, as defined below
- Severe influenza infection criteria:
- Need for hospitalization
- One of the following:
- New infiltrate on chest x-ray (or any infiltrate if no prior chest x-ray or not known)
Show all 14Show fewer
- Severe tachypnea (more information on this criterion can be found in the protocol)
- Severe dyspnea
- Arterial oxygen saturation of 92% or less on room air by trans-cutaneous method
- Positive diagnostic testing for influenza, as defined by either rapid influenza antigen (Ag) positive (A or B) or qualitative reverse transcriptase-polymerase chain reaction (RT-PCR) positive for any influenza
- Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 10 days before study enrollment
- Avian influenza infection criteria:
- Nasal wash, nasopharyngeal aspirate, endotracheal aspirate, nasal swab, or throat swab that is RT-PCR positive influenza for H5 influenza
- Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 14 days before study enrollment
Who cannot join
- Received more than 72 hours of oseltamivir (six doses) within 14 days
- Received oseltamivir at higher than standard doses within the last 14 days or during current acute illness, whichever is longer
- History of allergy or severe intolerance of oseltamivir, as determined by the investigator
- Alternate explanation for the clinical findings, as determined by the investigator and with the information immediately available
- Creatine clearance less than 10 ml/minute
- Pregnant or breastfeeding
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Vietnam5 sites
National Hospital of Pediatrics
Hanoi
National Institute fof Infectious and Tropical Diseases
Hanoi
Children's Hospital #1
Ho Chi Minh City
Hospital for Tropical Diseases
Ho Chi Minh City
Pediatric Hospital #2
Ho Chi Minh City
Thailand4 sites
Queen Sirikit National Institute of Child Health
Bangkok
Siriraj Hospital Mahidol University
Bangkok
Bamrasnaradura Infectious Disease Institute
Nonthaburi
Chest Disease Institute
Nonthaburi
Singapore3 sites
Changi General Hospital
Singapore
National University Hospital, National University of Singapore
Singapore
Tan Tock Seng Hospital
Singapore
About this study
Official title: High-Dose Versus Standard-Dose Oseltamivir for the Treatment of Severe Influenza and Avian Influenza: A Phase II Double-Blind, Randomized Clinical Trial
Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
Read the detailed description
Two main types of influenza virus--Types A and B--are responsible for the seasonal flu epidemics that occur each year. The influenza A viruses can be broken down into subtypes based on two proteins on the surface of the virus: hemagglutinin (H) and neuraminidase (N). The A subtypes usually found in humans are H1N1, H1N2, and H3N2. Other A subtypes are found primarily in animals. For example, the "avian influenza virus" refers to an influenza A virus that is found chiefly in birds.
Although avian influenza does not usually affect humans, increasing numbers of cases of human infection from avian influenza virus H5N1 have been reported in the last several years. Because all influenza viruses have the ability to modify, there is concern that this trend of increasing cases may pose a threat of a future pandemic with a new H5N1 virus that could spread easily from person to person.
The H5N1 virus that has caused human infection in Asia is resistant to amantadine and rimantadine, two antiviral medications commonly used for treating people with influenza. Another antiviral medication, oseltamivir, is currently used to treat people with uncomplicated human influenza. The purpose of this study is to compare standard-dose oseltamivir and high-does oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza. The study will also attempt to identify how severe human influenza and avian influenza differ in the following factors: clinical manifestation, relationship between antiviral plasma concentrations and viral dynamics, and pathogenesis.
Upon meeting certain screening criteria, participants will be randomly assigned to receive oseltamivir either at a standard-dose level (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) or at a high-dose level (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function). Treatment will continue for 5 days, after which participants who meet clinical failure criteria will continue their assigned treatment for an additional 5 days. It is anticipated that participants will remain hospitalized through the course of treatment. On Day 0, which marks the first day of hospitalization, participants will undergo a medical review, physical examination, blood sampling, nasal swab, throat swab, anal swab, and chest x-ray. An endotracheal aspirate procedure and urine sampling may also be performed. During the hospital stay, most of the above procedures will be repeated regularly, and additional samples of lung fluid, cerebral spinal fluid, and pleural fluid may be obtained. On Day 5 and possibly on Day 10, participants will undergo a follow-up x-ray. If applicable, participants will attend outpatient study visits on Days 10, 14, and 28 for further evaluation; participants with avian influenza will also attend visits on Days 56 and 180.
- Conditions
- Influenza, Avian Influenza, Severe Influenza
- Being tested
- Oseltamivir
- Keywords
- Antibody Response, Antiviral Efficacy, Bird Flu, Severe Respiratory Distress, Viral Replication and Shedding
- Medical subject headings
- Influenza, Human, Influenza in Birds, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Also called Tamiflu
Oseltamivir is a sialic acid analogue that potently and specifically inhibits the viral neuraminidases by competitively and reversibly interacting with the active enzyme site of influenza A and B viruses. Oseltamivir will be administered orally in standard formulations (capsules for adults and children at least 15 years of age; suspension for children younger than 15 years).
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose oseltamivir adult cohort | Active comparator | All participants >= 15 years will receive standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. Receives: Drug: Oseltamivir |
| Double Dose oseltamivir Adult cohort | Active comparator | All participants >= 15 years will receive high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. Receives: Drug: Oseltamivir |
| Standard Dose Oseltamivir child cohort | Active comparator | All participants <15 years will receive standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. Receives: Drug: Oseltamivir |
| Double Dose Oseltamivir child cohort | Active comparator | All Participants <15 years will receive high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of All Participants Negative for Viral RNA on Day 5
Proportion of all participants with no detectable viral RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) in a combined nasal and throat swab sample on day 5.
Measured: After 5 days of treatment
Secondary outcomes (5)
Participants Meeting Criteria for Day 5 Clinical Failure
Proportion of participants that have clinical failure by day 5. Subjects that meet one of the following on Day 5 will be classified as a clinical failure:
- Severe tachypnea (respiratory rate ≥ 30 for ages ≥12 years, rate ≥ 40 for ages 6 to 12 years, rate ≥45 for ages 3 to 6 years, rate ≥ 50 for ages 1 to 3 years)
- Severe dyspnea (unable to speak full sentences, or use of accessory respiratory muscles)
- Arterial oxygen saturation ≤92% on room air by trans-cutaneous method
- Need for mechanical ventilation or intensive care unit (ICU) admission For the purpose of endpoint definition, death prior to or on Day 5 will also be considered a clinical failure at Day 5.
Measured: After 5 days of treatment
In-hospital Mortality Rates
Standard therapy with oseltamivir is five days. Those patients with persistent symptoms on day five were continued on the randomized dose for an additional five days and assessments were performed up to day 10.
Measured: After up to 10 days of treatment
Median Time (Days) Receipt of Oxygen
Measured: Throughout study, 14 days
Median Time (Days) in ICU
Measured: Throughout study, 14 days
Median Time (Days) on Ventilation
Use of mechanical ventilation at any time for subjects with severe influenza and avian influenza.
Measured: Throughout study, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Wellcome Trust, World Health Organization, University of Oxford
- Responsible party
- Principal investigator, Jeremy Farrar, Oxford University Clinical Research Unit, Vietnam
- Investigators
- Tawee Chotpitayasunohdh, MD, Principal investigator, Queen Sirikit National Institute of Child Health, Bangkok, ThailandTran Tinh Hien, MD, Principal investigator, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298233
- Sponsor's protocol ID
- SEA 001
- Other IDs
- N01A050042
- Status last verified
- May 2014
- First submitted
- 1 Mar 2006
- Last updated
- 6 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
PubMed 8903148Colman PM. Influenza virus neuraminidase: structure, antibodies, and inhibitors. Protein Sci. 1994 Oct;3(10):1687-96. doi: 10.1002/pro.5560031007.
PubMed 7849585de Jong MD, Bach VC, Phan TQ, Vo MH, Tran TT, Nguyen BH, Beld M, Le TP, Truong HK, Nguyen VV, Tran TH, Do QH, Farrar J. Fatal avian influenza A (H5N1) in a child presenting with diarrhea followed by coma. N Engl J Med. 2005 Feb 17;352(7):686-91. doi: 10.1056/NEJMoa044307.
PubMed 15716562South East Asia Infectious Disease Clinical Research Network. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial. BMJ. 2013 May 30;346:f3039. doi: 10.1136/bmj.f3039.
PubMed 23723457
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Versus Standard-Dose Oseltamivir for the Treatment of Severe Influenza and Avian Influenza: A Phase II Double-Blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00298233
- Acronym / sponsor ID
- SEA 001
- Conditions
- Influenza, Avian Influenza, Severe Influenza
- Keywords
- Antibody Response, Antiviral Efficacy, Bird Flu, Severe Respiratory Distress, Viral Replication and Shedding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Wellcome Trust, World Health Organization, University of Oxford
- Study start
- Feb 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.
Detailed description
Two main types of influenza virus--Types A and B--are responsible for the seasonal flu epidemics that occur each year. The influenza A viruses can be broken down into subtypes based on two proteins on the surface of the virus: hemagglutinin (H) and neuraminidase (N). The A subtypes usually found in humans are H1N1, H1N2, and H3N2. Other A subtypes are found primarily in animals. For example, the "avian influenza virus" refers to an influenza A virus that is found chiefly in birds.
Although avian influenza does not usually affect humans, increasing numbers of cases of human infection from avian influenza virus H5N1 have been reported in the last several years. Because all influenza viruses have the ability to modify, there is concern that this trend of increasing cases may pose a threat of a future pandemic with a new H5N1 virus that could spread easily from person to person.
The H5N1 virus that has caused human infection in Asia is resistant to amantadine and rimantadine, two antiviral medications commonly used for treating people with influenza. Another antiviral medication, oseltamivir, is currently used to treat people with uncomplicated human influenza. The purpose of this study is to compare standard-dose oseltamivir and high-does oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza. The study will also attempt to identify how severe human influenza and avian influenza differ in the following factors: clinical manifestation, relationship between antiviral plasma concentrations and viral dynamics, and pathogenesis.
Upon meeting certain screening criteria, participants will be randomly assigned to receive oseltamivir either at a standard-dose level (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) or at a high-dose level (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function). Treatment will continue for 5 days, after which participants who meet clinical failure criteria will continue their assigned treatment for an additional 5 days. It is anticipated that participants will remain hospitalized through the course of treatment. On Day 0, which marks the first day of hospitalization, participants will undergo a medical review, physical examination, blood sampling, nasal swab, throat swab, anal swab, and chest x-ray. An endotracheal aspirate procedure and urine sampling may also be performed. During the hospital stay, most of the above procedures will be repeated regularly, and additional samples of lung fluid, cerebral spinal fluid, and pleural fluid may be obtained. On Day 5 and possibly on Day 10, participants will undergo a follow-up x-ray. If applicable, participants will attend outpatient study visits on Days 10, 14, and 28 for further evaluation; participants with avian influenza will also attend visits on Days 56 and 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Dose oseltamivir adult cohort | Active comparator | Drug: OseltamivirAll participants >= 15 years will receive standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. |
| Double Dose oseltamivir Adult cohort | Active comparator | Drug: OseltamivirAll participants >= 15 years will receive high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. |
| Standard Dose Oseltamivir child cohort | Active comparator | Drug: OseltamivirAll participants <15 years will receive standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. |
| Double Dose Oseltamivir child cohort | Active comparator | Drug: OseltamivirAll Participants <15 years will receive high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- At least one of the following respiratory symptoms: cough, dyspnea, sore throat
- Evidence of severe influenza or avian influenza, as defined below
- Severe influenza infection criteria:
- Avian influenza infection criteria:
Key exclusion criteria (6 listed)
- Received more than 72 hours of oseltamivir (six doses) within 14 days
- Received oseltamivir at higher than standard doses within the last 14 days or during current acute illness, whichever is longer
- History of allergy or severe intolerance of oseltamivir, as determined by the investigator
- Alternate explanation for the clinical findings, as determined by the investigator and with the information immediately available
- Creatine clearance less than 10 ml/minute
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: TamifluOseltamivir is a sialic acid analogue that potently and specifically inhibits the viral neuraminidases by competitively and reversibly interacting with the active enzyme site of influenza A and B viruses. Oseltamivir will be administered orally in standard formulations (capsules for adults and children at least 15 years of age; suspension for children younger than 15 years). | Drug | Double Dose Oseltamivir child cohort, Double Dose oseltamivir Adult cohort, Standard Dose Oseltamivir child cohort, Standard Dose oseltamivir adult cohort |
Primary outcome
Proportion of All Participants Negative for Viral RNA on Day 5
Time frame: After 5 days of treatment
Proportion of all participants with no detectable viral RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) in a combined nasal and throat swab sample on day 5.
5 secondary outcomes
Participants Meeting Criteria for Day 5 Clinical Failure
Time frame: After 5 days of treatment
In-hospital Mortality Rates
Time frame: After up to 10 days of treatment
Median Time (Days) Receipt of Oxygen
Time frame: Throughout study, 14 days
Median Time (Days) in ICU
Time frame: Throughout study, 14 days
Median Time (Days) on Ventilation
Time frame: Throughout study, 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8903148Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
- Background: PubMed 7849585Colman PM. Influenza virus neuraminidase: structure, antibodies, and inhibitors. Protein Sci. 1994 Oct;3(10):1687-96. doi: 10.1002/pro.5560031007.
- Background: PubMed 15716562de Jong MD, Bach VC, Phan TQ, Vo MH, Tran TT, Nguyen BH, Beld M, Le TP, Truong HK, Nguyen VV, Tran TH, Do QH, Farrar J. Fatal avian influenza A (H5N1) in a child presenting with diarrhea followed by coma. N Engl J Med. 2005 Feb 17;352(7):686-91. doi: 10.1056/NEJMoa044307.
- Results publication: PubMed 23723457South East Asia Infectious Disease Clinical Research Network. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial. BMJ. 2013 May 30;346:f3039. doi: 10.1136/bmj.f3039.
- South East Asian Infectious Diseases Clinical Research Network - Protocol and support documents availableLink provided by the sponsor.
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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.
Tawee Chotpitayasunohdh, MD principal investigator
Queen Sirikit National Institute of Child Health, Bangkok, Thailand
Tran Tinh Hien, MD principal investigator
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oseltamivir in people with Influenza and Avian Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in 3 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 14 inclusion and 6 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: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Vietnam, Thailand, Singapore. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of All Participants Negative for Viral RNA on Day 5 (time frame: After 5 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298233, which also lists 4 linked publications.
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 6 Jun 2014.