A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

Influenza Clinical Trial

Official title:

A Randomized, Multicenter Trial of Oseltamivir [Tamiflu] Doses of 75 mg for 5 or 10 Days Versus 150 mg for 5 or 10 Days to Evaluate the Effect on the Duration of Viral Shedding in Influenza Patients With Pandemic (H1N1) 2009

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01032837
• Other study ID #: NV22155
• Status: Terminated
• Phase: Phase 4
• First received: December 10, 2009
• Last updated: September 18, 2012
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Pediatric, adolescent and adult patients >/=1 year of age

• Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)

• Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug

• </=96 hours between onset of influenza-like illness and first dose of oseltamivir

Exclusion Criteria:

• Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration

• History of chronic renal failure or clinical suspicion of renal failure at baseline

• Clinical evidence of hepatic compensation at the time of randomization

• Known HIV infection

• Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Oseltamivir
Oseltamivir capsules for participants = 13 years.
• Oseltamivir
Pediatric suspension for participants aged = 12 years.
• Placebo
Matching placebo provided as capsules and as a suspension.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Cessation of Viral Shedding	The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.	Day 1 to Day 40	No
Secondary	Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture	Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.	Baseline and Days 3, 6, 8, 11, 15 and 40	No
Secondary	Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction	Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.	Baseline and Days 3, 6, 8, 11, 15 and 40	No
Secondary	Change From Baseline in Influenza Titer Measured by Viral Culture	Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).	Baseline, Days 2 through 15	No
Secondary	Number of Participants With Development of Oseltamivir-Resistant Influenza Virus	The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.	40 days	No
Secondary	Time to Resolution of Fever	Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or = 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is = 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.	Day 1 through Day 40	No
Secondary	Time to Alleviation of All Clinical Symptoms - Children	Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score =1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.	Day 1 to Day 40	No
Secondary	Time to Alleviation of All Clinical Symptoms - Adults	Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score =1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.	Day 1 to Day 40	No
Secondary	Number of Participants Who Developed Secondary Illnesses During the Study	The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.	Day 1 through Day 40	No
Secondary	Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics	The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.	Day 1 through Day 40	No