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A Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Adult and Adolescent Hospitalized Subjects With Confirmed or Suspected Influenza Infection - NCT00957996-(Clinical Trial 351548)



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City:  Milwaukee
State:  
WI
Zip Code:
Conditions: Seasonal Influenza - Cough - Sore Throat - Nasal Congestion - Myalgia - Headache - Feverishness - Fatigue
Purpose: This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in adult and adolescent hospitalized subjects with confirmed or suspected influenza infection.
Study summary:
Criteria: Inclusion Criteria: - Males and non-pregnant female subjects aged 12 years 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 oral temperature of ≥38.0 °C (100.4 °F) and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat or cough. - Confirmation of influenza A or B infection in the local community by one of the following means: a) the institution's local laboratory, or b) the local public health system or c) the national public health system or d) a laboratory of a recognized national or multinational influenza surveillance scheme. - Severity of illness requiring or anticipated to require in-hospital care. - Females of childbearing potential must report one of the following: - Subject is surgically sterile or clinically post-menopausal. - Subject has been sexually abstinent 4 weeks prior to date of screening evaluation and is willing to remain abstinent through 4 weeks after study-drug administration. - Subject has been using oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches for 3 months prior to the study, and use will continue through 4 weeks after study-drug administration. - Subject has been using an intra-uterine device, or adequate double-barrier method such as condom or diaphragm with spermicidal gel or foam as birth control 4 weeks prior to date of Screening evaluation, and use will continue through 4 weeks after study drug administration. - Subject is the spouse or monogamous partner of a male who has undergone a vasectomy. Exclusion Criteria: - Subjects who have developed clinical manifestations of influenza after having been hospitalized for greater than 24 hours for a condition other than confirmed or suspected influenza. - 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. - Requirement for vasopressor support to maintain satisfactory hemodynamic status 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 lactating. - Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. - 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 regimen (HAART) for at least 6 months. - Presence of a pre-existing chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). Subjects with chronic osteomyelitis are not excluded. - Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study. - Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the screening evaluation.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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