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InfluenzaPhase 2NCT00453999

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

A Phase 2 study testing Peramivir 200 mg, Peramivir 400 mg and Oseltamivir in people with Influenza, run by BioCryst Pharmaceuticals at 83 sites in 7 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

This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
Peramivir 200 mg, Peramivir 400 mg and Oseltamivir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
83 sitesin 7 countries
Study dates
Jul 2007to Aug 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

  • Age ≥18 years of age, male or female
  • Able to provide informed consent, or for whom consent may be provided by guardian
  • Presence of fever at time of screening of ≥38.0°C (≥ 100.0°F) taken orally, or ≥38.5°C (≥101.2°F) taken rectally. This requirement is waived if the subject has (1) a history of fever within 24 hours prior to screening and administered any antipyretic(s) in the 24 hours prior to screening, or (2) has no history of documented fever as defined above, but reports a symptom of feverishness at some time during 48 hours prior to screening
  • Presence of at least 1 respiratory symptom (cough, sore throat, nasal congestion/symptoms) of any severity (mild, moderate, severe)
  • Presence of at least 1 constitutional symptom (headache, myalgia, feverishness, malaise, fatigue) of any severity (mild, moderate, severe)
  • Onset of illness no more than 72 hours before presentation. Time of onset of illness defined as either (1) the time when temperature (oral or rectal) was elevated (at least 1°C of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least 1 respiratory symptom AND the presence of at least 1 constitutional symptom
Show all 20Show fewer
  • Presence of 1 or more of the following factors in a subject willing to be hospitalized for inpatient observation and treatment:
  • Age ≥60 years
  • Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy
  • History of congestive heart failure with or without medically significant recent change in cardiac status, but without signs or symptoms compatible with NYHA Class IV functional status
  • Presence of diabetes mellitus, clinically stable or unstable
  • Transcutaneous oxygen saturation <94% without supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value
  • Systolic blood pressure <90 mmHg
  • Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care
  • Positive rapid antigen test (RAT) for influenza A and/or influenza B (using an approved test kit) or other test for influenza virus antigen performed in a clinical laboratory at the screening/enrollment evaluation
  • Females of childbearing potential must report one of the following:
  • Be surgically sterile or clinically post-menopausal
  • 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 for all perimenopausal women or women of child-bearing potential
  • 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 for all perimenopausal women or women of child-bearing potential
  • 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 for all perimenopausal women or women of child-bearing potential

Who cannot join

  • Immunized against influenza with live attenuated virus vaccine in the previous weeks
  • Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in the previous 7 days
  • Current clinical evidence of a recognized or suspected acute non-influenzal infectious illness with onset prior to Screening
  • Serum creatinine laboratory result at Screening >1.6 mg/dL or a result >25% above the upper limit of normal for the laboratory performing the test
  • History of clinically significant proteinuria (≥1000 mg/24 hrs)
  • History of moderate or severe renal impairment and/or previous clinical laboratory data indicating an estimated creatinine clearance <50 mL/min during the previous 12 months
Show all 19Show fewer
  • Electrocardiogram (ECG) at Screening visit showing evidence of acute ischemia, or presence of a medically significant dysrhythmia
  • Presence of cardiac signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina (see NYHA Appendix V)
  • Presence of diagnosed COPD or other chronic lung condition requiring either continuous or intermittent oxygen therapy as an outpatient. Note: Subjects who are determined to require acute supplemental oxygen therapy at the time of Screening and/or at hospital admission may be enrolled, if exclusion criteria #13 or #14 are not applicable.
  • History of organ transplantation during the previous 12 months
  • Known HIV infection with most recent CD4+ T-cell count ≤350 cells/mL
  • History of diagnosis of any type of cancer (hematologic or solid tumor), that has required chemotherapy or radiation therapy in the previous 12 months, excluding non-melanomatous localized skin cancer
  • Presence of ongoing requirement for chronic mechanical ventilation, either via oral or nasotracheal intubation or via tracheostomy, or chronic or intermittent requirement for BiPAP (bilevel positive airway pressure) at screening. Note: Subjects who require intermittent CPAP treatment for sleep apnea (without oxygen supplementation) may be enrolled
  • Subjects who require acute mechanical ventilatory support of any type at the time of screening.
  • History of alcohol abuse or drug addiction during the previous 12 months
  • Participation in a clinical study of an experimental medication or other treatment during the previous 4 weeks
  • Previous treatment with intravenous or intramuscular peramivir
  • Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
  • Subjects who have been hospitalized due to a condition other than acute influenza and in whom influenza is diagnosed during hospitalization.

Trial locations and contacts

83 sites in 7 countries.

83 sites in 7 countries

United States41 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • VA Maryland Health Care System

    Baltimore, Maryland, 21201

  • Franklin Square Hospital

    Baltimore, Maryland, 21237

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Lowcountry Infectious Diseases, P.A.

    Charleston, South Carolina, 29414

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106-5083

  • Infectious Disease Specialists of Atlanta, P.C.

    Decatur, Georgia, 30033

  • National Jewish Medical and Research Center, Clinical Research Unit

    Denver, Colorado, 80206

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Hackensack University Medical Center, Department of Infectious Disease

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Idaho Falls Infectious Diseases, PLLC

    Idaho Falls, Idaho, 83404

  • Wishard Hospital/Indiana University

    Indianapolis, Indiana, 46202

  • Infectious Disease of Indiana, PSC

    Indianapolis, Indiana, 46280

  • St. Bernards Research Center/Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449-5703

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3522

  • Pulmonary Associates of Mobile, P.C.

    Mobile, Alabama, 36608

  • Natchitoches Internal Medicine

    Natchitoches, Louisiana, 71457

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.

    Orange, California, 92868

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Orlando Regional Healthcare

    Orlando, Florida, 32806

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Rochester General Hospital/University of Rochester

    Rochester, New York, 14621-3001

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Medical Center, Department of Emergency Medicine

    Sacramento, California, 95817

  • Veterans Affairs Medical Center

    Salem, Virginia, 24153

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • Good Samaritan Hospital

    San Jose, California, 95124

  • St. Joseph's/Candler Health System, Inc.

    Savannah, Georgia, 31405

  • Louisiana State University Health Sciences Center-Shreveport

    Shreveport, Louisiana, 71103

  • Springfield Clinic, LLP

    Springfield, Illinois, 62701

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Franciscan Health System

    Tacoma, Washington, 98405

  • James A. Haley Veterans Hospital, Department of Infectious Disease

    Tampa, Florida, 33612

  • William Beaumont Hospital Troy

    Troy, Michigan, 48085

Other trials in United States

South Africa14 sites

  • Benmed / Pentagon Hospital

    Benoni, Gauteng, 1500

  • Genclin Corporation

    Bloemfontein, Free State, 9301

  • Private Practice

    Cape Town, Gauteng, 1724

  • N1 City Hospital

    Cape Town, WC, 7460

  • Sebastian, P

    Durban, KZ-Natal, 4001

  • Newgate Centre

    Johannesburg, Gauteng, 2001

  • DJW Navorsing

    Krugersdorp, Gauteng, 1739

  • Eksteen, MC

    Mbombela, Mpumalanga, 1201

  • Global Clinical Trial Center

    Port Elizabeth, E. Cape, 6020

  • Medforum Hospital

    Pretoria, Gauteng, 0001

  • Eugene Marais Hospital

    Pretoria, Gauteng, 0084

  • Global Clinical Trials (GCT)

    Pretoria, Gauteng, 0186

  • Dr Bhorat

    Soweto, Gauteng, 1818

  • Dr. L.J. van Zyl

    Worcester, W Cape, 6850

Other trials in South Africa

Canada10 sites

  • Center de Sante et des Services Sociaux de Chicoutimi

    Chicoutimi, Quebec, G7H 5H6

  • Hamilton Health Sciences-McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • St. Joseph's Healthcare Hamilton-L424

    Hamilton, Ontario, L8N 4A6

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y 3T1

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier Universitaire de Quebec-Pavillon CHUL

    Québec, Quebec, G1V 4G2

  • Centre de sante et de services sociaux Rimouski-Neigette (CSSSRN)

    Rimouski, Quebec, G5L 5T1

  • Division of Infectious Diseases

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital / Toronto Medical Laboratories

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Australia9 sites

  • Cairns Base Hospital

    Cairns, Queensland, 4870

  • Repatriation General Hospital

    Daw Park, South Australia, 5041

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6060

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Prince Of Wales Hospital

    Randwick, New South Wales, 2031

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Gold Coast Hospital

    Southport, Queensland, 4215

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Hong Kong4 sites

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • United Christian Hospital

    Hong Kong

  • The Prince of Wales Hospital

    Shatin - New Territories

Other trials in Hong Kong

New Zealand3 sites

  • Christchurch Hospital

    Christchurch

  • Waikato Hospital

    Hamilton

  • Tauranga Hospital

    Tauranga, 3110

Other trials in New Zealand

Singapore2 sites

  • National University Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

Official title: Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing Efficacy and Safety of Intravenous Peramivir Once Daily Versus Oral Oseltamivir Twice Daily in Adults With Acute Serious or Potentially Life-Threatening Influenza

This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.

Conditions
Influenza
Being tested
Peramivir 200 mg, Peramivir 400 mg, Oseltamivir
Keywords
influenza, flu
Medical subject headings
Influenza, Human

What participants receive

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

  • Peramivir 200 mgDrug

    Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment

  • Peramivir 400 mgDrug

    Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)

  • OseltamivirDrug

    Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)

Study groups in NCT00453999
Study groupRoleWhat they receive
Arm 1: Peramivir 200 mgExperimentalPeramivir 200 mg administered intravenously once daily for 5 days (5 doses)
Receives: Drug: Peramivir 200 mg
Arm 2: Peramivir 400 mgExperimentalPeramivir 400 mg administered intravenously once daily for 5 days (5 doses)
Receives: Drug: Peramivir 400 mg
Arm 3: OseltamivirExperimentalOseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)
Receives: Drug: Oseltamivir

What is being measured

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

  1. Time to Clinical Stability (Kaplan-Meier Estimate)

    Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).

    Measured: 14 days

Secondary outcomes (5)

  1. Change From Baseline in Scores of Symptoms of Influenza

    Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (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]) were tabulated by treatment group. Missing data were excluded.

    Measured: Baseline, Days 2, 3, 4, 5, 10, and 14

  2. Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)

    Changes in each subject's ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject's ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).

    Measured: 14 days

  3. Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)

    The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.

    Measured: 14 days

  4. Time to Hospital Discharge (Kaplan-Meier Estimate)

    Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.

    Measured: 14 days

  5. Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)

    Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.

    Measured: Baseline, and 12, 24, 36, 48, 72, and 96 hours

Timeline

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

  1. First posted29 Mar 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionSep 2008
  4. Study completionAug 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00453999
Sponsor's protocol ID
BCX1812-201
Status last verified
Jan 2015
First submitted
27 Mar 2007
Last updated
12 Feb 2015
Data monitoring committee
Yes

Publications

  • Ison MG, Hui DS, Clezy K, O'Neil BJ, Flynt A, Collis PJ, Simon TJ, Alexander WJ. A clinical trial of intravenous peramivir compared with oral oseltamivir for the treatment of seasonal influenza in hospitalized adults. Antivir Ther. 2013;18(5):651-61. doi: 10.3851/IMP2442. Epub 2012 Oct 30.

    PubMed 23111657

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peramivir 200 mg, Peramivir 400 mg and Oseltamivir in people with Influenza, run by BioCryst Pharmaceuticals at 83 sites in 7 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 20 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 12 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 83 sites in United States, South Africa, Canada, Australia, Hong Kong and 2 more countries. 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. 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 12 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 Clinical Stability (Kaplan-Meier Estimate) (time frame: 14 days). 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 NCT00453999, which also lists 1 linked publication.

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 12 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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