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Acute, Uncomplicated Human InfluenzaPhase 2NCT00705406

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

A Phase 2 study testing Peramivir in people with Acute, Uncomplicated Human Influenza, run by BioCryst Pharmaceuticals at 123 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute, Uncomplicated Human Influenza
What is being tested?
Peramivir
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
405 participants
Where
123 sitesin 4 countries
Study dates
Jul 2008to Oct 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 19Show fewer
  • 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.

Trial locations and contacts

123 sites in 4 countries.

123 sites in 4 countries

United States67 sites

  • Integrated Medical Research, PC

    Ashland, Oregon, 97520

  • Acadia Clinical Research

    Bangor, Maine, 44401

  • Gulf Coast Research, LLC

    Baton Rouge, Louisiana, 70808

  • Northwest Clinical Research Center

    Bellevue, Washington, 98004

  • Impact Clinical Trials

    Beverly Hills, California, 90211

  • West Alabama Research, Inc.

    Birmingham, Alabama, 35209

  • Greystone Medical Research, LLC

    Birmingham, Alabama, 35242

  • Dr. Arthur Davida

    Bloomingdale, Illinois, 60108

  • Alpine Research Center

    Boulder, Colorado, 80304

  • Bozeman Urgent Care Center

    Bozeman, Montana, 59715

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Miray Medical Center

    Brockton, Massachusetts, 02301

  • DiscoveResearch, Inc.

    Bryan, Texas, 77802

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Community Medical Associates, LLC

    Canfield, Ohio, 44515

  • Medcenter

    Carmichael, California, 95608

  • 1st Allergy and Clinical Research Center

    Centennial, Colorado, 80112

  • Clarksburg Medical Center

    Clarksburg, Maryland, 20871

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Corpus Christi Family Wellness Center, Research Division

    Corpus Christi, Texas, 78414

  • New England Center for Clinical Research, Inc.

    Cranston, Rhode Island, 02920

  • Notheast Clinical Research

    Cumberland, Rhode Island, 02864

  • Allergy/Immunology Research Center of North Texas

    Dallas, Texas, 75230

  • Detroit Receiving Hospital, UHC 6G

    Detroit, Michigan, 48201

  • Medical Associates Clinic

    Dubuque, Iowa, 52001

  • Prairie Fields Family Medicine, P.C.

    Fremont, Nebraska, 68025

  • Towngate Plaza Medical Center

    Garland, Texas, 75041

  • Bland Clinic

    Greensboro, North Carolina, 27401

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • West Houston Clinical Research

    Houston, Texas, 77055

  • Idaho Falls Infectious Diseases

    Idaho Falls, Idaho, 83404

  • Investigators Research Group, LLC

    Indianapolis, Indiana, 46268

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • United Medical Associates

    Johnson City, New York, 13790

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • NEA Clinic

    Jonesboro, Arkansas, 72401

  • Impact Clinical Trials, Las Vegas

    Las Vegas, Nevada, 89106

  • North Central Arkansas Medical Associates

    Mountain Home, Arkansas, 72653

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Dean Medical Center

    Oregon, Wisconsin, 53575

  • Urgent Care of Green County, PLLC

    Owasso, Oklahoma, 74055

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • University Clinical Research, Inc.

    Pembroke Pines, Florida, 33024

  • NextCare Institute for Clinical Research

    Phoenix, Arizona, 85016

  • DMI Research, Inc.

    Pinellas Park, Florida, 33782

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Twelve Corners Internal Medicine

    Rochester, New York, 14618

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • KMED Research

    Saint Claire Shores, Michigan, 48081

  • Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies

    Saint Cloud, Florida, 34769

  • J. Lewis Research, Inc., FirstMed

    Salt Lake City, Utah, 84088

  • J. Lewis Research, Inc./Foothill Family Clinic South

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc./FirstMed East

    Salt Lake City, Utah, 84121

  • J. Lewis Research, Inc./Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Texas Medical Research Associates, LLC

    San Antonio, Texas, 78238

  • Coastal Medical Research Group, Inc.

    San Luis Obispo, California, 93405

  • Southeast Regional Research Group

    Savannah, Georgia, 31406

  • Heart of America Research

    Shawnee, Kansas, 66218

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Pivotal Clinical Research, LLC

    Souderton, Pennsylvania, 18964

  • Advanced Health Care Services, Inc

    Thornville, Ohio, 43076

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • The Kaufmann Clinic, Inc.

    Woodstock, Georgia, 30188

Other trials in United States

South Africa34 sites

  • Benmed Park Clinic

    Benoni, 1501

  • Jsha Research

    Bloemfontein, Bloemfontein, 9301

  • Quinta-Research

    Bloemfontein, Free State, 9301

  • Armansis Medical Centre

    Brits, 0250

  • NHC Medical Centre

    Bryanston, Gauteng, 2191

  • Kaapzicht Centre

    Cape Town, W. Cape, 7500

  • Syzygy SMO Intercare Medical and Dental Centre

    Cape Town, W. Cape, 7530

  • Cape Clinical Trial, Bishop Lavis Day Hospital

    Cape Town, 7490

  • First House

    Cape Town, 7941

  • Vawda, Z.FA

    Durban, KZ-Natal, 4091

  • Synapta Clinical Research Centre

    Durban, 4001

  • Dr. Janari

    Durban

  • Dr. van Rensburg

    eManzimtoti, 4126

  • Nortje, MD

    Goodwood, Capetown, 7460

  • Greenbury Medical Centre

    Greenbury, Durban, 4068

  • Dr. Makan

    Johannesburg, 1820

  • Newgate Centre

    Johannesburg

  • le Clus, MD

    Kempton Park, Pretoria, 1619

  • R. Dulabh, MD

    Klipspruit West, Gauteng, 1812

  • DJW Navorsing

    Noordheuwel, Krugersdorp, 1739

  • GCT Trials, Mercantile Hospital no 9

    Port Elizabeth

  • Dr. Nel

    Pretoria, 0083

  • Emmed Research

    Pretoria, 0084

  • Dr. de Bruin

    Pretoria, 9585

  • Westmed Clinical Trial Centre, Pretoria West Medicross Building

    Pretoria

  • Wilhase, AC

    Reigerpark, Gauteg, 1459

  • Dr. Fouche

    Roodepoort, 1724

  • Dr. de Villiers

    Scottburgh, 4182

  • Sebastian, MD

    Silverglen, Durban, 4092

  • Dr. Bhorat

    Soweto, 1818

  • Sunnyside Medi-Clinic

    Sunnyside Pretoria, Pretoria, 0132

  • Pillay, MD

    Verulam, KwaZulu-Natal, 4340

  • Clinical Project Research SA (Pty) Ltd.

    Worcester, W. Cape, 6850

  • Clinical Projects Research SA Ltd

    Worcester, 6850

Other trials in South Africa

Australia15 sites

  • Athelstone Medical Clinic

    Adelaide, 5076

  • Rivercity Private Hospital Specialist

    Auchenflower, Queensland, 4066

  • Pacific Medical Centre Blacktown

    Blacktown, New South Wales, 2148

  • Trialworks Clinical Research Services

    Brisbane

  • Dr Doongs Surgery

    Burwood

  • Caboolture Clinical Research Centre

    Caboolture, Queensland, 4510

  • Health Services -University of Melbourne

    Carlton, Victoria, 3053

  • East Sydney Doctors

    Darlinghurst, New South Wales, 2010

  • Holdsworth House Medical Practice

    Darlinghurst

  • Symbion Pathology

    Hurtsville, New South Wales, 2220

  • Peninsula Specialist Centre

    Kpparing, Queensland, 4021

  • Doctors of Ivanhoe,

    Melbourne

  • Lung Institute of Western Australia,

    Nedlands

  • Pitt Street Merrylands Medical Centre

    Sydney

  • Peninsula Medical Centre

    Umina, New South Wales, 2257

Other trials in Australia

New Zealand7 sites

  • Greenhithe Medical Centre

    Auckland

  • St George's Hospital

    Christchurch, Christchurch, 4737

  • Southern Clinical Trials Ltd

    Christchurch

  • Caversham Medical Centre

    Dunedin

  • Bairds Road Family Health Care

    Rotorua, Rotorua, 3010

  • Dr. Gillies

    Rotorua

  • Hinemoa House Family Health Centre

    Rotorua

Other trials in New Zealand

About this study

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

Being tested
Peramivir, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PeramivirDrug

    600 mg peramivir administered as bilateral 2-mL intramuscular injection

  • PlaceboDrug

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

Study groups in NCT00705406
Study groupRoleWhat they receive
Peramivir 600 mgExperimental600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Receives: Drug: Peramivir
PlaceboPlacebo comparatorPlacebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14

Secondary outcomes (1)

  1. 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).

    Measured: Baseline and Days 3, 4, 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionApr 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00705406
Sponsor's protocol ID
BCX1812-212
Other IDs
HHS 0100200700032C
Status last verified
Feb 2015
First submitted
24 Jun 2008
Last updated
16 Feb 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peramivir in people with Acute, Uncomplicated Human Influenza, run by BioCryst Pharmaceuticals at 123 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, South Africa, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Alleviation of Symptoms (Kaplan-Meier Estimate) (time frame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00705406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015; AzTrials last refreshed its copy on 28 Oct 2026.

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