InfluenzaIRISNCT00884117
Influenza Resistance Information Study
An observational study of Influenza, run by Hoffmann-La Roche at 8 sites in 8 countries.
Trial summary
This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- Oseltamivir
- How many people
- 4,561 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jan 2009to Nov 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled.
Who may be able to join
- Participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during Years 1 to 5)
- Participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during Years 6 and 7)
Who cannot join
- Allergy to any potential influenza therapy
- Living in the same household or residential/care home as another study participant
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: Influenza Resistance Information Study (IRIS)
This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.
- Conditions
- Influenza
- Being tested
- Oseltamivir
- Medical subject headings
- 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
Participants may receive treatment at the discretion of the investigator according to local practice standards, and there is no protocol-specified intervention. However, analyses will be presented separately for participants treated with oseltamivir during the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants Infected with Influenza | Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled and followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. Participants may receive treatment including oseltamivir, other treatment/medication, or no treatment. Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Genotypic Resistance
Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, "H" stands for hemagglutinin and "N" stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)
Measured: Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.
Measured: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7
Secondary outcomes (23)
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Measured: Baseline (Day 1)
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Measured: Day 3
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Measured: Day 6
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Measured: Day 10
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Measured: Baseline (Day 1)
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Measured: Day 3
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Measured: Day 6
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Measured: Day 10
Time to Non-Detection of Viral RNA
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Measured: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Measured: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Measured: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Measured: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Viral Load Among Adults Treated With Oseltamivir
Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL).
Measured: Days 1, 3, 6, 10
Viral Load Among Children Treated With Oseltamivir
Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL.
Measured: Days 1, 3, 6, 10
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses.
Measured: Day 6
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses.
Measured: Days 3, 6, 10
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses.
Measured: Baseline (Day 1)
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.
Measured: Days 1, 6, 10
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.
Measured: Days 1, 6, 10
Body Temperature Among Adults Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.
Measured: Days 1, 10
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.
Measured: Baseline (Day 1) to Day 10
Body Temperature Among Children Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.
Measured: Days 1, 10
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.
Measured: Baseline (Day 1) to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2015
- Study completionNov 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884117
- Sponsor's protocol ID
- NV20237
- Other IDs
- 2008-006149-24, 2008
- Acronym
- IRIS
- Status last verified
- Oct 2016
- First submitted
- 15 Apr 2009
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Roosenhoff R, Reed V, Kenwright A, Schutten M, Boucher CA, Monto A, Clinch B, Kumar D, Whitley R, Nguyen-Van-Tam JS, Osterhaus ADME, Fouchier RAM, Fraaij PLA. Viral Kinetics and Resistance Development in Children Treated with Neuraminidase Inhibitors: The Influenza Resistance Information Study (IRIS). Clin Infect Dis. 2020 Aug 22;71(5):1186-1194. doi: 10.1093/cid/ciz939.
PubMed 31560055Fraaij PL, Schutten M, Javouhey E, Burleigh L, Outlaw R, Kumar D, Boucher CA. Viral shedding and susceptibility to oseltamivir in hospitalized immunocompromised patients with influenza in the Influenza Resistance Information Study (IRIS). Antivir Ther. 2015;20(6):633-42. doi: 10.3851/IMP2957. Epub 2015 Apr 7.
PubMed 25849228
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Resistance Information Study (IRIS)
- ClinicalTrials.gov ID
- NCT00884117
- Acronym / sponsor ID
- IRIS / NV20237
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,561 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Posted 19 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Infected with Influenza | – | Drug: OseltamivirParticipants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled and followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. Participants may receive treatment including oseltamivir, other treatment/medication, or no treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness will be enrolled.
Key inclusion criteria (2 listed)
- Participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during Years 1 to 5)
- Participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during Years 6 and 7)
Key exclusion criteria (2 listed)
- Allergy to any potential influenza therapy
- Living in the same household or residential/care home as another study participant
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: TamifluParticipants may receive treatment at the discretion of the investigator according to local practice standards, and there is no protocol-specified intervention. However, analyses will be presented separately for participants treated with oseltamivir during the course of the study. | Drug | Participants Infected with Influenza |
Primary outcome
Number of Participants With Genotypic Resistance
Time frame: Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, "H" stands for hemagglutinin and "N" stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.
23 secondary outcomes
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Time frame: Baseline (Day 1)
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Time frame: Day 3
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Time frame: Day 6
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Time frame: Day 10
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Time frame: Baseline (Day 1)
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Time frame: Day 3
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Time frame: Day 6
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Time frame: Day 10
Time to Non-Detection of Viral RNA
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Viral Load Among Adults Treated With Oseltamivir
Time frame: Days 1, 3, 6, 10
Viral Load Among Children Treated With Oseltamivir
Time frame: Days 1, 3, 6, 10
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Time frame: Day 6
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Time frame: Days 3, 6, 10
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Time frame: Baseline (Day 1)
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Time frame: Days 1, 6, 10
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Time frame: Days 1, 6, 10
Body Temperature Among Adults Treated With Oseltamivir
Time frame: Days 1, 10
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Time frame: Baseline (Day 1) to Day 10
Body Temperature Among Children Treated With Oseltamivir
Time frame: Days 1, 10
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Time frame: Baseline (Day 1) to Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31560055Roosenhoff R, Reed V, Kenwright A, Schutten M, Boucher CA, Monto A, Clinch B, Kumar D, Whitley R, Nguyen-Van-Tam JS, Osterhaus ADME, Fouchier RAM, Fraaij PLA. Viral Kinetics and Resistance Development in Children Treated with Neuraminidase Inhibitors: The Influenza Resistance Information Study (IRIS). Clin Infect Dis. 2020 Aug 22;71(5):1186-1194. doi: 10.1093/cid/ciz939.
- Derived from this study: PubMed 25849228Fraaij PL, Schutten M, Javouhey E, Burleigh L, Outlaw R, Kumar D, Boucher CA. Viral shedding and susceptibility to oseltamivir in hospitalized immunocompromised patients with influenza in the Influenza Resistance Information Study (IRIS). Antivir Ther. 2015;20(6):633-42. doi: 10.3851/IMP2957. Epub 2015 Apr 7.
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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.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Hoffmann-La Roche at 8 sites in 8 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 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: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, France, Germany, Hong Kong and 3 more countries. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2016). 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?
Number of Participants With Genotypic Resistance (time frame: Baseline (Day 1) and post-Baseline (Days 3, 6, 10)). 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?
On the ClinicalTrials.gov record for NCT00884117, which also lists 2 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 19 Oct 2016.