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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00884117
Registration number
NCT00884117
Ethics application status
Date submitted
15/04/2009
Date registered
20/04/2009
Date last updated
19/10/2016
Titles & IDs
Public title
Influenza Resistance Information Study
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Scientific title
Influenza Resistance Information Study (IRIS)
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Secondary ID [1]
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2008-006149-24
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Secondary ID [2]
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NV20237
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Universal Trial Number (UTN)
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Trial acronym
IRIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Oseltamivir
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.
Treatment: Drugs: Oseltamivir
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Genotypic Resistance
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Assessment method [1]
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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.)
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Timepoint [1]
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Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
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Primary outcome [2]
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Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
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Assessment method [2]
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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.
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Timepoint [2]
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From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7
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Secondary outcome [1]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
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Assessment method [1]
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Timepoint [1]
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Baseline (Day 1)
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Secondary outcome [2]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
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Assessment method [2]
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Timepoint [2]
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Day 3
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Secondary outcome [3]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
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Assessment method [3]
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Timepoint [3]
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Day 6
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Secondary outcome [4]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
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Assessment method [4]
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Timepoint [4]
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Day 10
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Secondary outcome [5]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
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Assessment method [5]
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Timepoint [5]
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Baseline (Day 1)
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Secondary outcome [6]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
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Assessment method [6]
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Timepoint [6]
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Day 3
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Secondary outcome [7]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
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Assessment method [7]
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Timepoint [7]
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Day 6
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Secondary outcome [8]
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Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
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Assessment method [8]
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Timepoint [8]
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Day 10
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Secondary outcome [9]
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Time to Non-Detection of Viral RNA
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Assessment method [9]
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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.
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Timepoint [9]
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From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
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Secondary outcome [10]
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Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
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Assessment method [10]
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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.
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Timepoint [10]
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From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
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Secondary outcome [11]
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Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
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Assessment method [11]
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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.
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Timepoint [11]
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From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
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Secondary outcome [12]
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Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
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Assessment method [12]
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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.
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Timepoint [12]
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From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
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Secondary outcome [13]
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Viral Load Among Adults Treated With Oseltamivir
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Assessment method [13]
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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).
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Timepoint [13]
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Days 1, 3, 6, 10
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Secondary outcome [14]
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Viral Load Among Children Treated With Oseltamivir
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Assessment method [14]
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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.
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Timepoint [14]
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Days 1, 3, 6, 10
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Secondary outcome [15]
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Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
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Assessment method [15]
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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.
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Timepoint [15]
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Day 6
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Secondary outcome [16]
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Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
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Assessment method [16]
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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.
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Timepoint [16]
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Days 3, 6, 10
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Secondary outcome [17]
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Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline (Day 1)
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Secondary outcome [18]
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Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
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Assessment method [18]
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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.
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Timepoint [18]
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Days 1, 6, 10
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Secondary outcome [19]
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Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
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Assessment method [19]
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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.
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Timepoint [19]
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Days 1, 6, 10
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Secondary outcome [20]
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Body Temperature Among Adults Treated With Oseltamivir
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Assessment method [20]
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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.
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Timepoint [20]
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Days 1, 10
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Secondary outcome [21]
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Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline (Day 1) to Day 10
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Secondary outcome [22]
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Body Temperature Among Children Treated With Oseltamivir
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Assessment method [22]
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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.
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Timepoint [22]
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Days 1, 10
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Secondary outcome [23]
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Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline (Day 1) to Day 10
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Eligibility
Key inclusion criteria
- 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)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Allergy to any potential influenza therapy
- Living in the same household or residential/care home as another study participant
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2015
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Sample size
Target
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Accrual to date
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Final
4561
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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France
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State/province [2]
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Bron
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Country [3]
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Germany
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State/province [3]
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Berlin
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Country [4]
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Hong Kong
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State/province [4]
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Shatin
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Country [5]
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Netherlands
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State/province [5]
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Rotterdam
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Country [6]
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Norway
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State/province [6]
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Sandnes
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Country [7]
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Poland
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State/province [7]
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Krakow
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00884117
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00884117
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