Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza

Influenza Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00610935
• Other study ID #: BCX1812 311
• Secondary ID: HHS # O100200700
• Status: Terminated
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: February 2008

Study information

• Verified date: February 2021
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and non-pregnant female subjects age =18 years.

• A positive Influenza A and/or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one-hour.

• 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. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.

• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.

• Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity.

• Onset of symptoms no more than 48 hours before presentation for screening.

• Written informed consent.

Exclusion Criteria:

• Women who are pregnant or breast-feeding.

• Presence of clinically significant signs of acute respiratory distress.

• History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma (See section 15.2).

• History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.

• Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.

• History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min).

• Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.

• Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.

• Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.

• Currently receiving treatment for viral hepatitis B or viral hepatitis C.

• Presence of known HIV infection with a CD4 count <350 cell/mm3.

• Current therapy with oral warfarin or other systemic anticoagulant.

• Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.

• Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.

• Immunized against influenza with inactivated virus vaccine within the previous 14 days.

• Receipt of any intramuscular injection within the previous 14 days.

• History of alcohol abuse or drug addiction within 1 year prior to admission in the study.

• Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.

• Participation in a study of any investigational drug or device within the last 30 days.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Peramivir
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.
• Placebo
Single intramuscular injection

Locations

Country	Name	City	State
United States	NuLife Clinical Research, Inc.	Anaheim	California
United States	Integrated Medical Research PC	Ashland	Oregon
United States	Gulf Coast Research, LLC	Baton Rouge	Louisiana
United States	DiscoveResearch Inc.	Beaumont	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Professional Clinical Research-Benzonia	Benzonia	Michigan
United States	Impact Clinical Trials	Beverly Hills	California
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Clinical Research Department	Bozeman	Montana
United States	Holston Medical Group, PC	Bristol	Tennessee
United States	DiscoveResearch, Inc.	Bryan	Texas
United States	Associated Pharmaceutical Research Center, Inc.	Buena Park	California
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Professional Clinical Research, Inc.	Cadillac	Michigan
United States	Community Medical Partners	Canfield	Ohio
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Parsons Avenue Medical Clinic	Columbus	Ohio
United States	Intrinsic Research Data, Inc.	Corpus Christi	Texas
United States	New England Center for Clinical Research, Inc.	Cranston	Rhode Island
United States	Allergy/Immunology Research Center of North Texas	Dallas	Texas
United States	Research Across America	Dallas	Texas
United States	Medical Associates Clinic PC	Dubuque	Iowa
United States	Physician Care PM	Edmond	Oklahoma
United States	Health Sciences Research Center at Asthma & Allergy Associates P.C.	Elmira	New York
United States	Med Investigations Incorporated	Fair Oaks	California
United States	Prarie Fields Family Medicine, P.C	Fremont	Nebraska
United States	Research Center of Fresno, Inc	Fresno	California
United States	Universal Biopharma Research Institute Inc.	Fresno	California
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Harmony Clinical, Inc.	Garden Grove	California
United States	Andras Koser	Greenville	South Carolina
United States	Paris View Family Practice	Greenville	South Carolina
United States	Quick Care Medical	Hamilton	New Jersey
United States	Kentucky Lung Clinic	Hazard	Kentucky
United States	AGA Clinical Trials	Hialeah	Florida
United States	Eastern Research	Hialeah	Florida
United States	Century Clinical Research Inc	Holly Hill	Florida
United States	Dynamed Clinical Research, L.P.	Houston	Texas
United States	West Houston Clinical Research Service	Houston	Texas
United States	Investigators Research Group, LLC	Indianapolis	Indiana
United States	Professional Clinical Research-Interlochen	Interlochen	Michigan
United States	Health Sciences Research Center	Ithaca	New York
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Office of Roger J. Miller, Jr., MD	Jacksonville	Florida
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Clopton Clinic	Jonesboro	Arkansas
United States	Research Solutions, LLC	Jonesboro	Arkansas
United States	Holston Medical Group, P.C.	Kingsport	Tennessee
United States	Gulf Coast Research LLC	Lafayette	Louisiana
United States	MD Now Medical Center	Lake Worth	Florida
United States	DMI Healthcare Group	Largo	Florida
United States	Allergy, Asthma, and Respiratory Care Medical Center	Long Beach	California
United States	Longmont Clinic, P.C.	Longmont	Colorado
United States	National Institute of Clinical Research	Los Angeles	California
United States	Ohio Clinical Research LLC	Lyndhurst	Ohio
United States	Well Pharma Medical Research, Corp.	Miami	Florida
United States	Physical Express	Millbrook	Alabama
United States	Kevin Adkins, MD	Mountain Home	Arkansas
United States	Welborn Clinic Gateway	Newburgh	Indiana
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Compass Research LLC	Orlando	Florida
United States	Urgent Care of Green County	Owasso	Oklahoma
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Pines Research, LLC	Pembroke Pines	Florida
United States	HOPE Research Institute	Phoenix	Arizona
United States	Primary Physicians Research Inc.	Pittsburgh	Pennsylvania
United States	Quincy Medical Group	Quincy	Illinois
United States	American Institute of Healthcare & Fitness	Raleigh	North Carolina
United States	Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research	Richmond	Virginia
United States	KMED Research	Saint Clair Shores	Michigan
United States	Wilker/Powers Center for Clinical Studies	Saint Cloud	Florida
United States	J. Lewis Research Inc	Salt Lake City	Utah
United States	J. Lewis Research Inc. Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research, Inc.	Salt Lake City	Utah
United States	Optimum Clinical Research	Salt Lake City	Utah
United States	GSA Research	San Antonio	Texas
United States	San Antonio Preventive and Diagnostic Medicine	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	San Diego Sports Medicine and Family Health Center	San Diego	California
United States	Coastal Medical Research Group, Inc.	San Luis Obispo	California
United States	Sandersville Family Practice Center	Sandersville	Georgia
United States	Physicians Research Options, LLC	Saratoga Springs	Utah
United States	Heart of America Research Institute	Shawnee Mission	Kansas
United States	Byron Jackson	Shreveport	Louisiana
United States	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	Clinvest	Springfield	Missouri
United States	American Medical Exams, P.A.	Topeka	Kansas
United States	Alabama Family Medical Center	Tuscaloosa	Alabama
United States	Warminster Medical Associates, PC	Warminster	Pennsylvania
United States	Holston Medical Group	Weber City	Virginia
United States	J. Lewis Research Inc. FirstMed	West Jordan	Utah
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Winchester, Patton, Burgess, PSC	Whitley City	Kentucky
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Time to Alleviation of Clinical Signs and Symptoms of Influenza	The primary efficacy endpoint was the time to alleviation of symptoms of influenza in subjects diagnosed with influenza, defined as the time from injection of study drug to the start of the time period when a subject had Alleviation of Symptoms. A subject had Alleviation of Symptoms if each of the seven symptoms of influenza (cough, sore throat, nasal obstruction, myalgia [aches and pains], headache, feverishness, and fatigue) as self-assessed and recorded in the subject diary were either absent or were present at no more than mild severity level and at this status for at least 21.5 hours (24 hours minus 10%). No statistical testing was performed.	Up to 14 days
Secondary	To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.	The change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group. The differences between the treatment groups were planned to be evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID50/mL were obtained at interval visits after treatment. As the study was terminated prematurely, no statistical testing was performed on these data.	Change from baseline assessed on days 3, 5 and 9.