Influenza Resistance Information Study (IRIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,561
- 主要终点
- Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Allergy to any potential influenza therapy
- •Living in the same household or residential/care home as another study participant
研究组 & 干预措施
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.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
时间窗: 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.
Number of Participants With Genotypic Resistance
时间窗: 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.)
次要结局
- Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir(Day 3)
- Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections(From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10))
- Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir(Baseline (Day 1))
- Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir(Day 10)
- Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir(Baseline (Day 1))
- Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir(Day 10)
- Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir(Day 3)
- Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir(Day 6)
- Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir(Day 6)
- Time to Non-Detection of Viral RNA(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(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(From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10))
- Viral Load Among Adults Treated With Oseltamivir(Days 1, 3, 6, 10)
- Viral Load Among Children Treated With Oseltamivir(Days 1, 3, 6, 10)
- Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses(Day 6)
- Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses(Days 3, 6, 10)
- Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load(Baseline (Day 1))
- Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir(Days 1, 6, 10)
- Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir(Days 1, 6, 10)
- Body Temperature Among Adults Treated With Oseltamivir(Days 1, 10)
- Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir(Baseline (Day 1) to Day 10)
- Body Temperature Among Children Treated With Oseltamivir(Days 1, 10)
- Change From Baseline in Body Temperature Among Children Treated With Oseltamivir(Baseline (Day 1) to Day 10)