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A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

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ClinicalTrials.gov Identifier: NCT01053663
Recruitment Status : Terminated (The study was terminated prematurely after three influenza seasons.)
First Posted : January 21, 2010
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Influenza
Intervention Drug: Tamiflu
Enrollment 9
Recruitment Details  
Pre-assignment Details A total of 2428 participants were prescreened; of which, 2419 failed the prescreening evaluation. The most common reasons for failing the prescreening evaluation included the following: negative influenza diagnosis, not meeting the age criterion, ability to tolerate/absorb oral medication, and inability to comply with the study procedures.
Arm/Group Title Oseltamivir - All Participants
Hide Arm/Group Description Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Period Title: Overall Study
Started 9
Completed 3
Not Completed 6
Reason Not Completed
Death             2
Lost to Follow-up             1
Poor IV Access             1
Transferred to Another Hospital             1
Negative Influenza Diagnosis             1
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Total
Hide Arm/Group Description Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Total of all reporting groups
Overall Number of Baseline Participants 7 1 1 9
Hide Baseline Analysis Population Description
All-participants population included all participants who were enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 7 participants 1 participants 1 participants 9 participants
175.0  (62.0) 41.0 23.0 143.2  (82.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 1 participants 1 participants 9 participants
Female
2
  28.6%
0
   0.0%
0
   0.0%
2
  22.2%
Male
5
  71.4%
1
 100.0%
1
 100.0%
7
  77.8%
1.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 0 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanogram/milliliter (h*ng/mL)
Oseltamivir
777
(162.8%)
494
Oseltamivir Carboxylate
5200
(87.8%)
7510
2.Primary Outcome
Title AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
Oseltamivir
988
(57.8%)
481
Oseltamivir Carboxylate
7270
(42.2%)
5330
3.Primary Outcome
Title AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 2 0 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
Oseltamivir
1520
(33.9%)
389
Oseltamivir Carboxylate
3880
(98.0%)
2070
4.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 0 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
Oseltamivir
307
(315.7%)
203
Oseltamivir Carboxylate
736
(55.5%)
871
5.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir
419
(78.4%)
194
Oseltamivir Carboxylate
1080
(43.6%)
1050
6.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 2 0 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir
742
(31.1%)
189
Oseltamivir Carboxylate
1370
(89.6%)
727
7.Secondary Outcome
Title Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 1 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
Day 1: Oseltamivir (n = 3, 0, 1)
2.51
(55.4%)
NA [1] 
(NA%)
2.00
Day 1: Oseltamivir Carboxylate (n = 3, 0, 1)
4.57
(32.5%)
NA [1] 
(NA%)
5.58
Day 2: Oseltamivir (n = 3, 1, 0)
2.02
(1.4%)
2.13
NA [1] 
(NA%)
Day 2: Oseltamivir Carboxylate (n = 3, 1, 0)
3.40
(47.8%)
4.30
NA [1] 
(NA%)
Day 4: Oseltamivir (n = 2, 0, 1)
2.02
(1.2%)
NA [1] 
(NA%)
1.93
Day 4: Oseltamivir Carboxylate (n = 2, 0, 1)
3.85
(6.7%)
NA [1] 
(NA%)
3.98
[1]
Data not available as no participant was evaluable.
8.Secondary Outcome
Title Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 1 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1: Oseltamivir (n = 3, 0, 1)
5.58
(183.0%)
NA [1] 
(NA%)
2.76
Day 1: Oseltamivir Carboxylate (n = 3, 0, 1)
505
(82.9%)
NA [1] 
(NA%)
503
Day 2: Oseltamivir (n = 3, 1, 0)
8.22
(183.5%)
6.84
NA [1] 
(NA%)
Day 2: Oseltamivir Carboxylate (n = 3, 1, 0)
849
(67.9%)
948
NA [1] 
(NA%)
Day 4: Oseltamivir (n = 2, 0, 1)
66.2
(28.8%)
NA [1] 
(NA%)
10.7
Day 4: Oseltamivir Carboxylate (n = 2, 0, 1)
1370
(89.6%)
NA [1] 
(NA%)
727
[1]
Data not available as no participant was evaluable.
9.Secondary Outcome
Title Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 3 1 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
Day 1: Oseltamivir (n = 3, 0, 1)
9.62
(24.7%)
NA [1] 
(NA%)
10.58
Day 1: Oseltamivir Carboxylate (n = 3, 0, 1)
9.62
(24.7%)
NA [1] 
(NA%)
10.58
Day 2: Oseltamivir (n = 3, 1, 0)
8.55
(51.1%)
6.47
NA [1] 
(NA%)
Day 2: Oseltamivir Carboxylate (n = 3, 1, 0)
8.55
(51.1%)
6.47
NA [1] 
(NA%)
Day 4: Oseltamivir (n = 2, 0, 1)
3.85
(6.7%)
NA [1] 
(NA%)
3.98
Day 4: Oseltamivir Carboxylate (n = 2, 0, 1)
3.85
(6.7%)
NA [1] 
(NA%)
3.98
[1]
Data not available as no participant was evaluable.
10.Secondary Outcome
Title Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values
Hide Description IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either ≥5 times change in the NAI IC50 visit value from the Reference value at a visit or ≥5 times change in the NAI IC50 Visit value from the Baseline value.
Time Frame Baseline, Days 1, 3, 4, 6, 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Oseltamivir: All Participants
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 4 0 1 5
Measure Type: Number
Unit of Measure: participants
Day 1 (n=4, 0, 1, 5) 1 0 1
Day 3 (n=0, 0, 1, 1) NA [1]  0 0
Day 4 (n=3, 0, 0, 3) 1 NA [1]  1
Day 6 (n=0, 0, 1, 1) NA [1]  0 0
Day 15 (n=1, 0, 0, 1) 0 NA [1]  0
[1]
Data not available as no participant was evaluable in this arm for specified time-point.
11.Secondary Outcome
Title Number of Participants With Oseltamivir Resistance Mutation
Hide Description Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
Time Frame Up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Oseltamivir: All Participants
Hide Arm/Group Description:
Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 7 1 1 9
Measure Type: Number
Unit of Measure: participants
1 0 0 1
Time Frame Up to Day 30
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Oseltamivir: All Participants
Hide Arm/Group Description Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
All-Cause Mortality
Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Oseltamivir: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Oseltamivir: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   0/1 (0.00%)   0/1 (0.00%)   5/9 (55.56%) 
General disorders         
Multi−Organ Failure * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Cerebral Ischaemia * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory Disorder * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Respiratory Distress * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Respiratory Failure * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oseltamivir: Age 91 to < 365 Days Oseltamivir: Age 31 to 90 Days Oseltamivir: Age 0 to 30 Days Oseltamivir: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   0/1 (0.00%)   1/1 (100.00%)   5/9 (55.56%) 
Blood and lymphatic system disorders         
Thrombocytopenia * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Cardiac disorders         
Sinus Bradycardia * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Gastrointestinal disorders         
Abdominal Distension * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Vomiting * 1  0/7 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/9 (11.11%) 
General disorders         
Application Site Vesicles * 1  0/7 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders         
Hypokalaemia * 1  0/7 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/9 (11.11%) 
Nervous system disorders         
Brain Oedema * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders         
Proteinuria * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary Hypertension * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders         
Rash * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
Vascular disorders         
Haemorrhage * 1  0/7 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  1/9 (11.11%) 
Hypotension * 1  1/7 (14.29%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01053663     History of Changes
Other Study ID Numbers: NP25138
First Submitted: January 20, 2010
First Posted: January 21, 2010
Results First Submitted: January 15, 2016
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016