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A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

Primary Purpose

Acute, Uncomplicated Human Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Peramivir
Placebo
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute, Uncomplicated Human Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and non-pregnant female subjects age ≥18 years.
  • A positive Influenza A 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 36 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.
  • History of heart failure or angina 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 with the previous 7 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.

Sites / Locations

  • West Alabama Research, Inc.
  • Greystone Medical Research, LLC
  • NextCare Institute for Clinical Research
  • Clopton Clinic
  • NEA Clinic
  • North Central Arkansas Medical Associates
  • Impact Clinical Trials
  • Medcenter
  • Center for Clinical Trials, LLC
  • Coastal Medical Research Group, Inc.
  • Alpine Research Center
  • 1st Allergy and Clinical Research Center
  • Clinical Research of South Florida
  • Westside Center for Clinical Research
  • Jacksonville Center for Clinical Research
  • University Clinical Research, Inc.
  • DMI Research, Inc.
  • Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies
  • Southeast Regional Research Group
  • Southeast Regional Research Group
  • The Kaufmann Clinic, Inc.
  • Idaho Falls Infectious Diseases
  • Dr. Arthur Davida
  • Investigators Research Group, LLC
  • Medical Associates Clinic
  • Heart of America Research
  • Kentucky Lung Clinic
  • Gulf Coast Research, LLC
  • Acadia Clinical Research
  • Clarksburg Medical Center
  • Miray Medical Center
  • Detroit Receiving Hospital, UHC 6G
  • William Beaumont Hospital
  • KMED Research
  • Olive Branch Family Medical Center
  • Bozeman Urgent Care Center
  • Mercury Street Medical Group, PLLC
  • Prairie Fields Family Medicine, P.C.
  • Impact Clinical Trials, Las Vegas
  • United Medical Associates
  • Twelve Corners Internal Medicine
  • Bland Clinic
  • Community Medical Associates, LLC
  • Advanced Health Care Services, Inc
  • Urgent Care of Green County, PLLC
  • Integrated Medical Research, PC
  • Pivotal Clinical Research, LLC
  • New England Center for Clinical Research, Inc.
  • Notheast Clinical Research
  • Clinical Partners, LLC
  • Omega Medical Research
  • Hillcrest Clinical Research, LLC
  • Health Concepts
  • Holston Medical Group
  • DiscoveResearch, Inc.
  • Corpus Christi Family Wellness Center, Research Division
  • Allergy/Immunology Research Center of North Texas
  • Towngate Plaza Medical Center
  • West Houston Clinical Research
  • Texas Medical Research Associates, LLC
  • Martin Diagnostic Clinic
  • J. Lewis Research, Inc., FirstMed
  • J. Lewis Research, Inc./Foothill Family Clinic South
  • J. Lewis Research, Inc./FirstMed East
  • J. Lewis Research, Inc./Foothill Family Clinic South
  • Northwest Clinical Research Center
  • Dean Medical Center
  • Pacific Medical Centre Blacktown
  • East Sydney Doctors
  • Symbion Pathology
  • Peninsula Medical Centre
  • Rivercity Private Hospital Specialist
  • Caboolture Clinical Research Centre
  • Peninsula Specialist Centre
  • Health Services -University of Melbourne
  • Athelstone Medical Clinic
  • Trialworks Clinical Research Services
  • Dr Doongs Surgery
  • Holdsworth House Medical Practice
  • Doctors of Ivanhoe,
  • Lung Institute of Western Australia,
  • Pitt Street Merrylands Medical Centre
  • Greenhithe Medical Centre
  • St George's Hospital
  • Southern Clinical Trials Ltd
  • Caversham Medical Centre
  • Bairds Road Family Health Care
  • Dr. Gillies
  • Hinemoa House Family Health Centre
  • Nortje, MD
  • Greenbury Medical Centre
  • Sebastian, MD
  • Quinta-Research
  • Wilhase, AC
  • NHC Medical Centre
  • R. Dulabh, MD
  • DJW Navorsing
  • Pillay, MD
  • Vawda, Z.FA
  • le Clus, MD
  • Sunnyside Medi-Clinic
  • Kaapzicht Centre
  • Syzygy SMO Intercare Medical and Dental Centre
  • Clinical Project Research SA (Pty) Ltd.
  • Dr. van Rensburg
  • Benmed Park Clinic
  • Jsha Research
  • Armansis Medical Centre
  • Cape Clinical Trial, Bishop Lavis Day Hospital
  • First House
  • Synapta Clinical Research Centre
  • Dr. Janari
  • Dr. Makan
  • Newgate Centre
  • GCT Trials, Mercantile Hospital no 9
  • Dr. Nel
  • Emmed Research
  • Dr. de Bruin
  • Westmed Clinical Trial Centre, Pretoria West Medicross Building
  • Dr. Fouche
  • Dr. de Villiers
  • Dr. Bhorat
  • Clinical Projects Research SA Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peramivir 600 mg

Placebo

Arm Description

600 mg peramivir administered as bilateral 2-mL intramuscular injection.

Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Outcomes

Primary Outcome Measures

Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.

Secondary Outcome Measures

Change in Influenza Virus Shedding
Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).

Full Information

First Posted
June 24, 2008
Last Updated
February 12, 2015
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00705406
Brief Title
A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
Official Title
A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute, Uncomplicated Human Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peramivir 600 mg
Arm Type
Experimental
Arm Description
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Intervention Type
Drug
Intervention Name(s)
Peramivir
Intervention Description
600 mg peramivir administered as bilateral 2-mL intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Primary Outcome Measure Information:
Title
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Description
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Time Frame
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Secondary Outcome Measure Information:
Title
Change in Influenza Virus Shedding
Description
Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).
Time Frame
Baseline and Days 3, 4, 9
Other Pre-specified Outcome Measures:
Title
Subject's Severity of Illness (Score*Hours)
Description
A subject's severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized. The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21.
Time Frame
Information collected predose on Day 1 and then once daily through Day 14
Title
Time to Resolution of Fever
Description
Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.
Time Frame
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Title
Incidence of Influenza-related Complications
Description
Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.
Time Frame
14 days
Title
Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)
Description
Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.
Time Frame
Baseline
Title
Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)
Description
Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.
Time Frame
Baseline and up to 14 days
Title
Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)
Description
Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Time Frame
Baseline and up to 14 days
Title
Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)
Description
Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Time Frame
Baseline and up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and non-pregnant female subjects age ≥18 years. A positive Influenza A 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 36 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. History of heart failure or angina 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 with the previous 7 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.
Facility Information:
Facility Name
West Alabama Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Greystone Medical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
NextCare Institute for Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Clopton Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
North Central Arkansas Medical Associates
City
Mountain Home
State/Province
Arkansas
ZIP/Postal Code
72653
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Medcenter
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Coastal Medical Research Group, Inc.
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Alpine Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
1st Allergy and Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
DMI Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Southeast Regional Research Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
The Kaufmann Clinic, Inc.
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Facility Name
Idaho Falls Infectious Diseases
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Dr. Arthur Davida
City
Bloomingdale
State/Province
Illinois
ZIP/Postal Code
60108
Country
United States
Facility Name
Investigators Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States
Facility Name
Medical Associates Clinic
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Heart of America Research
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Kentucky Lung Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Gulf Coast Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Acadia Clinical Research
City
Bangor
State/Province
Maine
ZIP/Postal Code
44401
Country
United States
Facility Name
Clarksburg Medical Center
City
Clarksburg
State/Province
Maryland
ZIP/Postal Code
20871
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Detroit Receiving Hospital, UHC 6G
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
KMED Research
City
St. Claire Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Bozeman Urgent Care Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Prairie Fields Family Medicine, P.C.
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Impact Clinical Trials, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
United Medical Associates
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Twelve Corners Internal Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Bland Clinic
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Community Medical Associates, LLC
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
Facility Name
Advanced Health Care Services, Inc
City
Thornville
State/Province
Ohio
ZIP/Postal Code
43076
Country
United States
Facility Name
Urgent Care of Green County, PLLC
City
Owasso
State/Province
Oklahoma
ZIP/Postal Code
74055
Country
United States
Facility Name
Integrated Medical Research, PC
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Pivotal Clinical Research, LLC
City
Souderton
State/Province
Pennsylvania
ZIP/Postal Code
18964
Country
United States
Facility Name
New England Center for Clinical Research, Inc.
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Notheast Clinical Research
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Corpus Christi Family Wellness Center, Research Division
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Allergy/Immunology Research Center of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Towngate Plaza Medical Center
City
Garland
State/Province
Texas
ZIP/Postal Code
75041
Country
United States
Facility Name
West Houston Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Texas Medical Research Associates, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research, Inc., FirstMed
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
J. Lewis Research, Inc./Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc./FirstMed East
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research, Inc./Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Dean Medical Center
City
Oregon
State/Province
Wisconsin
ZIP/Postal Code
53575
Country
United States
Facility Name
Pacific Medical Centre Blacktown
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
East Sydney Doctors
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Symbion Pathology
City
Hurtsville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Facility Name
Peninsula Medical Centre
City
Umina
State/Province
New South Wales
ZIP/Postal Code
2257
Country
Australia
Facility Name
Rivercity Private Hospital Specialist
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Caboolture Clinical Research Centre
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
Peninsula Specialist Centre
City
Kpparing
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Health Services -University of Melbourne
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Athelstone Medical Clinic
City
Adelaide
ZIP/Postal Code
5076
Country
Australia
Facility Name
Trialworks Clinical Research Services
City
Brisbane
Country
Australia
Facility Name
Dr Doongs Surgery
City
Burwood
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
Country
Australia
Facility Name
Doctors of Ivanhoe,
City
Melbourne
Country
Australia
Facility Name
Lung Institute of Western Australia,
City
Nedlands
Country
Australia
Facility Name
Pitt Street Merrylands Medical Centre
City
Sydney
Country
Australia
Facility Name
Greenhithe Medical Centre
City
Auckland
Country
New Zealand
Facility Name
St George's Hospital
City
Christchurch
ZIP/Postal Code
4737
Country
New Zealand
Facility Name
Southern Clinical Trials Ltd
City
Christchurch
Country
New Zealand
Facility Name
Caversham Medical Centre
City
Dunedin
Country
New Zealand
Facility Name
Bairds Road Family Health Care
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Dr. Gillies
City
Rotorua
Country
New Zealand
Facility Name
Hinemoa House Family Health Centre
City
Rotorua
Country
New Zealand
Facility Name
Nortje, MD
City
Goodwood
State/Province
Capetown
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Greenbury Medical Centre
City
Greenbury
State/Province
Durban
ZIP/Postal Code
4068
Country
South Africa
Facility Name
Sebastian, MD
City
Silverglen
State/Province
Durban
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Quinta-Research
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Wilhase, AC
City
Reigerpark
State/Province
Gauteg
ZIP/Postal Code
1459
Country
South Africa
Facility Name
NHC Medical Centre
City
Bryanston
State/Province
Gauteng
ZIP/Postal Code
2191
Country
South Africa
Facility Name
R. Dulabh, MD
City
Klipspruit West
State/Province
Gauteng
ZIP/Postal Code
1812
Country
South Africa
Facility Name
DJW Navorsing
City
Noordheuwel
State/Province
Krugersdorp
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Pillay, MD
City
Verulam
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4340
Country
South Africa
Facility Name
Vawda, Z.FA
City
Durban
State/Province
KZ-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
le Clus, MD
City
Kempton Park
State/Province
Pretoria
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Sunnyside Medi-Clinic
City
Sunnyside Pretoria
State/Province
Pretoria
ZIP/Postal Code
0132
Country
South Africa
Facility Name
Kaapzicht Centre
City
Cape Town
State/Province
W. Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Syzygy SMO Intercare Medical and Dental Centre
City
Cape Town
State/Province
W. Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Clinical Project Research SA (Pty) Ltd.
City
Worcester
State/Province
W. Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Dr. van Rensburg
City
Amanzimtoti
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Benmed Park Clinic
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Jsha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Armansis Medical Centre
City
Brits
ZIP/Postal Code
0250
Country
South Africa
Facility Name
Cape Clinical Trial, Bishop Lavis Day Hospital
City
Cape town
ZIP/Postal Code
7490
Country
South Africa
Facility Name
First House
City
Cape Town
ZIP/Postal Code
7941
Country
South Africa
Facility Name
Synapta Clinical Research Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Dr. Janari
City
Durban
Country
South Africa
Facility Name
Dr. Makan
City
Johannesburg
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Newgate Centre
City
Johannesburg
Country
South Africa
Facility Name
GCT Trials, Mercantile Hospital no 9
City
Port Elizabeth
Country
South Africa
Facility Name
Dr. Nel
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Dr. de Bruin
City
Pretoria
ZIP/Postal Code
9585
Country
South Africa
Facility Name
Westmed Clinical Trial Centre, Pretoria West Medicross Building
City
Pretoria
Country
South Africa
Facility Name
Dr. Fouche
City
Roodepoort
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Dr. de Villiers
City
Scottburgh
ZIP/Postal Code
4182
Country
South Africa
Facility Name
Dr. Bhorat
City
Soweto
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Clinical Projects Research SA Ltd
City
Worcester
ZIP/Postal Code
6850
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

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