- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050257
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Odense C, Denmark, 5000
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Bron, France, 69677
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Garches, France, 92380
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La Tronche, France, 38700
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Paris, France, 75970
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Paris, France, 75651
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Paris, France, 75679
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Tours, France, 37044
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Budapest, Hungary, 1125
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4012
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Eger, Hungary, 3300
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Gyor, Hungary, 9024
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Gyula, Hungary, 5700
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Kaposvar, Hungary, 7400
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Miskolc, Hungary, 3526
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Nyiregyhaza, Hungary, 4400
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Pecs, Hungary, 7624
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Szeged, Hungary, 6725
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Szolnok, Hungary, 5000
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Szombathely, Hungary, 9700
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Veszprem, Hungary, H-8200
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Genova, Italy, 16132
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Milano, Italy, 20157
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Monza, Italy, 20052
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Pavia, Italy, 27100
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Roma, Italy, 00149
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Kaunas, Lithuania, 47116
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Vilnius, Lithuania, 08117
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Bialystok, Poland, 15-540
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Chorzow, Poland, 41-500
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Radom, Poland, 26-610
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Warszawa, Poland, 01-201
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Bucharest, Romania, 21105
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Constanta, Romania, 8700
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Craiova, Romania, 200515
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Timisoara, Romania, 300310
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Almeria, Spain, 04009
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Madrid, Spain, 28905
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Alicante
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Elche, Alicante, Spain, 03203
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Alabama
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Birmingham, Alabama, United States, 35233
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Montgomery, Alabama, United States, 36106
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Arizona
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Phoenix, Arizona, United States, 85008
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Arkansas
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Little Rock, Arkansas, United States, 72205
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California
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Duarte, California, United States, 91010
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Los Angeles, California, United States, 90027
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San Diego, California, United States, 92120
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Delaware
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Wilmington, Delaware, United States, 19803
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Florida
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33126
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Pensacola, Florida, United States, 32504
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South Miami, Florida, United States, 33143
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Tampa, Florida, United States, 33606
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Georgia
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Atlanta, Georgia, United States, 30309
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Illinois
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612
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Maywood, Illinois, United States, 60153
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Iowa
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Des Moines, Iowa, United States, 50314
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Kansas
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Kansas City, Kansas, United States, 64128
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Overland Park, Kansas, United States, 66211
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Wichita, Kansas, United States, 67214
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Kentucky
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Madisonville, Kentucky, United States, 42431
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Louisiana
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New Orleans, Louisiana, United States, 70121
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Massachusetts
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Worcester, Massachusetts, United States, 01655
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Michigan
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Detroit, Michigan, United States, 48202
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Kalamazoo, Michigan, United States, 49007
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Minnesota
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Duluth, Minnesota, United States, 55805
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Minneapolis, Minnesota, United States, 55454
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Mississippi
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Jackson, Mississippi, United States, 39202
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Missouri
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St. Joseph, Missouri, United States, 64506
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Montana
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Butte, Montana, United States, 59701
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Nebraska
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Grand Island, Nebraska, United States, 68803
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New Jersey
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Holmdel, New Jersey, United States, 07733
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New York
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Bronx, New York, United States, 10467
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New York, New York, United States, 10032
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New York, New York, United States, 10065
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New York, New York, United States, 10007
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South Bronx, New York, United States, 10461
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Stony Brook, New York, United States, 11794
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North Carolina
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Charlotte, North Carolina, United States, 28233
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Akron, Ohio, United States, 44304
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Cincinnati, Ohio, United States, 45229
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Cincinnati, Ohio, United States, 45267
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Cleveland, Ohio, United States, 44109
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Dayton, Ohio, United States, 45404
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Youngstown, Ohio, United States, 44501
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
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Pittsburgh, Pennsylvania, United States, 15213-2582
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Texas
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Dallas, Texas, United States, 75216
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Dallas, Texas, United States, 75235
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San Antonio, Texas, United States, 78205
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San Antonio, Texas, United States, 78232
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Virginia
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Norfolk, Virginia, United States, 23510
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West Virginia
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Charleston, West Virginia, United States, 25304
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult and adolescent patients, 13 years of age and older
- Diagnosis of influenza
- ≤ 144 hours between the onset of influenza-like illness and first dose of study drug
Non-randomized, open-label treatment group:
- Patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 mL/min
Exclusion Criteria:
- Clinical evidence of severe hepatic decompensation at the time of randomization
- Acute ischemia or significant arrhythmia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Oseltamivir (TAMIFLU®) 100 mg
Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days.
At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment.
If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
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Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment.
Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Other Names:
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days.
Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Other Names:
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EXPERIMENTAL: Oseltamivir (TAMIFLU®) 200 mg
Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days.
At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days.
If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
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Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment.
Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Other Names:
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days.
Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Other Names:
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EXPERIMENTAL: Oseltamivir Open Label
Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol.
If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
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Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment.
Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Other Names:
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days.
Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death
Time Frame: Up to 30 days
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Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug. |
Up to 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacokinetics
Time Frame: Days 1, 3
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Days 1, 3
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Percentage of Participants With Viral Shedding by Culture or RT-PCR
Time Frame: Days 1, 4, 6, 11, 15 and 30
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Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis.
The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).
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Days 1, 4, 6, 11, 15 and 30
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Percentage of Participants With Viral Shedding by Culture
Time Frame: Days 1, 4, 6, 11, 15, 30
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Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis.
The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.
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Days 1, 4, 6, 11, 15, 30
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Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Time Frame: Days 1, 4, 6, 11, 15 and 30
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Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis.
The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).
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Days 1, 4, 6, 11, 15 and 30
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Change From Baseline in Influenza Titer by Culture at Day 4
Time Frame: Baseline, Day 4
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Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis.
Viral influenza titer (amount of virus present) was determined by culture.
A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture.
A negative change from Baseline indicated improvement (less virus present).
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Baseline, Day 4
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Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4
Time Frame: Baseline, Day 4
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Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis.
Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL).
A negative change from Baseline indicated improvement (less virus present).
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Baseline, Day 4
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Percentage of Participants Who Had a Fever During the Study
Time Frame: Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108
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Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).
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Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108
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Time to Resolution of Fever for Participants Who Had a Fever at Baseline
Time Frame: Baseline, Up to 30 Days
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Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius).
Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.
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Baseline, Up to 30 Days
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Number of Participants With Viral Resistance
Time Frame: 30 days
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Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing.
Viral resistance was determined by phenotypic and genotypic testing.
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30 days
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Percentage of Participants With Influenza Symptoms
Time Frame: Days 1, 11, 15, 30
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Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.
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Days 1, 11, 15, 30
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NV25118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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