A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

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
Placebo	Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Peramivir 600 mg	Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.

Participant Flow:   Overall Study

	Placebo	Peramivir 600 mg
STARTED	203	202
COMPLETED	199	197
NOT COMPLETED	4	5
Lost to Follow-up	3	3
Did not receive study drug	1	2

1.  Primary:

Time to Alleviation of Symptoms (Kaplan-Meier Estimate)   [ Time Frame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 ]

2.  Secondary:

Change in Influenza Virus Shedding   [ Time Frame: Baseline and Days 3, 4, 9 ]

3.  Other Pre-specified:

Subject’s Severity of Illness (Score*Hours)   [ Time Frame: Information collected predose on Day 1 and then once daily through Day 14 ]

4.  Other Pre-specified:

Time to Resolution of Fever   [ Time Frame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14 ]

5.  Other Pre-specified:

Incidence of Influenza-related Complications   [ Time Frame: 14 days ]

6.  Other Pre-specified:

Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)   [ Time Frame: Baseline ]

7.  Other Pre-specified:

Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)   [ Time Frame: Baseline and up to 14 days ]

8.  Other Pre-specified:

Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)   [ Time Frame: Baseline and up to 14 days ]

9.  Other Pre-specified:

Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)   [ Time Frame: Baseline and up to 14 days ]

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
The majority of the subjects enrolled in this study with a laboratory confirmed influenza infection were infected with an influenza A/H1N1 virus containing an H275Y mutation associated with reduced susecptibility to peramivir and oseltamivir.