Influenza Resistance Information Study (IRIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00884117
First received: April 15, 2009
Last updated: June 8, 2016
Last verified: June 2016
Results First Received: June 8, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Influenza
Intervention: Drug: Oseltamivir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants Infected With Influenza Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.

Participant Flow:   Overall Study
    All Participants Infected With Influenza  
STARTED     4561  
COMPLETED     4312 [1]
NOT COMPLETED     249  
Adverse Event                 2  
Withdrawal by Subject                 89  
Death                 3  
Lost to Follow-up                 143  
Not Specified                 12  
[1] Defined as Day 6 visit for those enrolled before Amendment D; thereafter defined as Day 10 visit.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Enrolled Participants (AEP) Population: All participants who entered the study regardless of completion status.

Reporting Groups
  Description
Otherwise Healthy Participants Infected With Influenza Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.

Baseline Measures
    Otherwise Healthy Participants Infected With Influenza  
Number of Participants  
[units: participants]
  4553  
Age  
[units: years]
Mean (Standard Deviation)
  19.5  (19.24)  
Gender  
[units: participants]
 
Female     2331  
Male     2222  



  Outcome Measures
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1.  Primary:   Number of Participants With Genotypic Resistance   [ Time Frame: Baseline (Day 1) and post-Baseline (Days 3, 6, 10) ]

2.  Primary:   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 ]

3.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir   [ Time Frame: Baseline (Day 1) ]

4.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir   [ Time Frame: Day 3 ]

5.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir   [ Time Frame: Day 6 ]

6.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir   [ Time Frame: Day 10 ]

7.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir   [ Time Frame: Baseline (Day 1) ]

8.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir   [ Time Frame: Day 3 ]

9.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir   [ Time Frame: Day 6 ]

10.  Secondary:   Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir   [ Time Frame: Day 10 ]

11.  Secondary:   Time to Non-Detection of Viral RNA   [ Time Frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) ]

12.  Secondary:   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) ]

13.  Secondary:   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) ]

14.  Secondary:   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) ]

15.  Secondary:   Viral Load Among Adults Treated With Oseltamivir   [ Time Frame: Days 1, 3, 6, 10 ]

16.  Secondary:   Viral Load Among Children Treated With Oseltamivir   [ Time Frame: Days 1, 3, 6, 10 ]

17.  Secondary:   Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses   [ Time Frame: Day 6 ]

18.  Secondary:   Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses   [ Time Frame: Days 3, 6, 10 ]

19.  Secondary:   Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load   [ Time Frame: Baseline (Day 1) ]

20.  Secondary:   Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir   [ Time Frame: Days 1, 6, 10 ]

21.  Secondary:   Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir   [ Time Frame: Days 1, 6, 10 ]

22.  Secondary:   Body Temperature Among Adults Treated With Oseltamivir   [ Time Frame: Days 1, 10 ]

23.  Secondary:   Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir   [ Time Frame: Baseline (Day 1) to Day 10 ]

24.  Secondary:   Body Temperature Among Children Treated With Oseltamivir   [ Time Frame: Days 1, 10 ]

25.  Secondary:   Change From Baseline in Body Temperature Among Children Treated With Oseltamivir   [ Time Frame: Baseline (Day 1) to Day 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a non-randomized, observational study and many comparisons were not powered to detect a true statistically significant difference between groups. Inferential analyses should be interpreted with caution.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00884117     History of Changes
Other Study ID Numbers: NV20237
2008-006149-24 ( EudraCT Number )
Study First Received: April 15, 2009
Results First Received: June 8, 2016
Last Updated: June 8, 2016
Health Authority: France: Agence Francaise de Securite Sanitaire des Produits de Sante