Loading clinical trials...

Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza

A Phase 3, Open-Label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza Infection

NCT00957996•BioCryst Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and non-pregnant female subjects 6 years of age or older.
•Able to provide written informed consent, or for whom written consent may be provided by a parent guardian or legally authorized representative, unless consent provided by a parent, guardian or legally authorized representative is not consistent with applicable local or ethical procedures, directives and /or guidelines.
•Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection; a measured temperature of ≥ 38.0°C (100.4°F) oral, or ≥ 38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can include fever meeting the above criteria as reported by the subject or their parent, guardian or legally authorized representative in the 24 hours prior to Screening. The requirement for fever is waived for any subject with influenza infection already confirmed by laboratory tests (including Rapid Antigen Tests).
•Confirmation of influenza A or B infection in the local community by one of the following means:
•the institution's local laboratory,
•the local public health system
•the national public health system
•a laboratory of a recognized national or multinational influenza surveillance scheme.
•Severity of illness requiring or anticipated to require in-hospital care.

Exclusion Criteria

•Subjects who have been hospitalized for greater than 24 hours (not including time spent in the emergency department).Blood platelet count of \< 20 x 109/L.
•Serum bilirubin \> 6 mg/dL at time of Screening evaluation.
•Serum ALT or AST \> 5 X upper limit of normal at time of Screening evaluation.
•Serum creatinine \> 5.0 mg/dL at time of Screening evaluation.
•Subjects who require peritoneal dialysis or hemofiltration.
•Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
•Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding.
•Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable).
•Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
•HIV infection with a known CD4 count \< 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months.
+5 more criteria

Locations (110)

Dothan, Alabama, United States

Mobile, Alabama, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Fountain Valley, California, United States

Harbor City, California, United States

La Mesa, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Modesto, California, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

October 1, 2010

Completion Date

August 1, 2011

Last Updated

February 12, 2015

Enrollment

234

ACTUAL participants

Conditions

Seasonal InfluenzaCoughSore ThroatNasal CongestionMyalgiaHeadacheFatigue

Interventions

Peramivir

DRUG

Peramivir

DRUG

Laryngeal Cryotherapy for Refractory Neurogenic Cough

NCT05665244

Upper-Airway Cough Syndrome

View study

RECRUITINGNA

Validation of the C-mo System - Cough Monitoring

NCT05989698

CoughAsthma+6 more

View study

RECRUITINGPHASE3

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza

Inclusion Criteria

Exclusion Criteria

Laryngeal Cryotherapy for Refractory Neurogenic Cough

Validation of the C-mo System - Cough Monitoring

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial

Different Models of Tracheal Catheters Are Used for Female Thyroid Glands

Development of a Cough Control Questionnaire (CCQ)