Status:
COMPLETED
Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00419263
Start Date
January 1 2007
End Date
September 1 2007
Last Update
February 12 2015
Active Locations (69)
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1
Radiant Research
Birmingham, Alabama, United States, 35209
2
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
3
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
4
Orange County Clinical Trials
Anaheim, California, United States, 92801