Influenza Clinical Trial
Official title:
A Phase II, Multicenter, Randomized, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.
This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.
Status | Completed |
Enrollment | 344 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age =18 years - Presence of fever at time of screening of =38.0 ºC (=100.4 ºF) taken orally, or =38.5 ºC (=101.2 ºF) taken rectally. However, this requirement is waived if the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening. - Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe) - Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe) - Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom. - Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment. - Females of childbearing potential must report one of the following: - Be surgically sterile - Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study drug administration - Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study drug administration - Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration. Exclusion Criteria: - Women who are breast-feeding - History of diagnosed chronic obstructive pulmonary disease or diagnosis of severe persistent asthma - History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min) - History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months - Immunocompromised status due to illness or previous organ transplant - Current use of systemic immunosuppressive medications (except inhaled corticosteroids) - Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days - Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days - Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics - Clinically significant signs of acute respiratory distress - Clinically significant signs of acute cardiac disease - Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia - Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es) - History of hepatitis B, hepatitis C, or human immunodeficiency virus infection - History of alcohol abuse or drug addiction within 1 year prior to admission in the study - Participation in a study of any investigational drug within the last 30 days - Positive urine pregnancy test |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Calgary West Medical Cnetre Clinical Studies | Calgary | Alberta |
Canada | Gain Medical Centre | Coquitlam | British Columbia |
Canada | Belvedere Medicentre | Edmonton | Alberta |
Canada | Castledowns Medicentre | Edmonton | Alberta |
Canada | Hermitage Medicentres | Edmonton | Alberta |
Canada | RJA Medicentres | Edmonton | Alberta |
Canada | Source Unique Clinic | Hawkesbury | Ontario |
Canada | Omnispec Clinical Reasearch Inc | Mirabel | Quebec |
Canada | Prairie Clinical | Saskatoon | Saskatchewan |
Canada | Clinique Medicale des Campus | Ste-Foy | Quebec |
Canada | Manna Research | Toronto | Ontario |
United States | Summa Health | Akron | Ohio |
United States | Alliance Medical Center | Alliance | Nebraska |
United States | Advanced Clinical Research Institute | Anaheim | California |
United States | Orange County Clinical Trials | Anaheim | California |
United States | Integrated Medical Research, PC | Ashland | Oregon |
United States | Georgia Clinical Research | Atlanta | Georgia |
United States | Kentucky Pediatric / Adult Research | Bardstown | Kentucky |
United States | Radiant Research | Birmingham | Alabama |
United States | Alpine Clinical Research Center | Boulder | Colorado |
United States | Bozeman Urgent Care Center | Bozeman | Montana |
United States | Brooklyn Hospital Center | Brooklyn | New York |
United States | Medical Center | Carmichael | California |
United States | UMDNJ | Cherry Hill | New Jersey |
United States | Sterling Research Group, LTD. | Cincinnati | Ohio |
United States | Clinical Research of Southern Florida | Coral Gables | Florida |
United States | New England Center for Clinical Research, Inc | Cranston | Rhode Island |
United States | Paragon Clinical Research, Inc. | Cranston | Rhode Island |
United States | Radiant Research | Dallas | Texas |
United States | Research Across America | Dallas | Texas |
United States | University Clinical Research-Deland, LLC | DeLand | Florida |
United States | Pulmonary & Critical Care Associates | East Brunswick | New Jersey |
United States | Radiant Research, Minneapolis | Edina | Minnesota |
United States | Pacific Sleep Medicines Service | El Centro | California |
United States | Florida Medical Research Institute | Gainesville | Florida |
United States | Towngate Plaza Medical Center | Garland | Texas |
United States | Baylor Clinic-Baylor College of Medicine | Houston | Texas |
United States | Wishard Hospital | Indianapolis | Indiana |
United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
United States | Clopton Clinic | Jonesboro | Arkansas |
United States | Research Across America at Oyster Point Family Health Center | Lancaster | Pennsylvania |
United States | Central Kentucky Research Assoc, Inc | Lexington | Kentucky |
United States | Benchmark Research | Metairie | Louisiana |
United States | Midwest Family Physicians | Omaha | Nebraska |
United States | Advanced Clinical Research Institute | Orange | California |
United States | Radiant Research | Overland Park | Kansas |
United States | Radiant Research | Philadelphia | Pennsylvania |
United States | Primary Physicians Research, Inc | Pittsburgh | Pennsylvania |
United States | Wake Research Associates, LLC | Raleigh | North Carolina |
United States | Benchmark Research | Sacramento | California |
United States | J. Lewis Research, Inc. Foothill Family Clinic | Salt Lake City | Utah |
United States | J. Lewis Research, Inc. Foothill Family Clinic South | Salt Lake City | Utah |
United States | GSA Research | San Antonio | Texas |
United States | Radiant Research San Antonio | San Antonio | Texas |
United States | Radiant Research-San Antonio Northeast | San Antonio | Texas |
United States | Pacific Sleep Medicine Services | San Diego | California |
United States | Pacific Sleep Medicine Services | San Francisco | California |
United States | Clinical Research Center | Sarasota | Florida |
United States | Hillcrest Family Practice | Simpsonville | South Carolina |
United States | Barnes-Jewish Hospital Emergency Department | St Louis | Missouri |
United States | Medex Healthcare Research, Inc. | St. Louis | Missouri |
United States | Radiant Research | St. Louis | Missouri |
United States | Balbir Chahal M.D. ,P.A | Tomball | Texas |
United States | Dynamed Clinical Research | Tomball | Texas |
United States | Omega Medical Research | Warwick | Rhode Island |
United States | George Washington Unviersity | Washington | District of Columbia |
United States | J. Lewis Research, Inc./Southwest Family Medicine | West Jordan | Utah |
United States | Palm Beach Research Center | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
BioCryst Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Alleviation of Symptoms (Kaplan-Meier Estimate) | Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed. | Up to 14 days | No |
Secondary | Time to Resolution of Fever | The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed. | Up to 14 days | No |
Secondary | Time to Resumption of Ability to Perform Usual Activities | The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment. | Up to 14 days | No |
Secondary | Change From Baseline to Day 2 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 24 hours after treatment | No |
Secondary | Change From Baseline to Day 3 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 48 hours after treatment | No |
Secondary | Change From Baseline to Day 5 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 96 hours after treatment | No |
Secondary | Change From Baseline to Day 9 in Influenza Virus Titer | The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment). | Baseline and approximately 192 hours after treatment | No |
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