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Clinical Trials/EUCTR2010-020083-38-PL
EUCTR2010-020083-38-PLActive, not recruitingNot Applicable

A Multicenter, Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged =13 Years

F. Hoffmann-La Roche Ltd0 sites200 target enrollmentStarted: December 20, 2010Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Male and female adults and adolescents, 13 years of age and older, except in Germany and Denmark, where the subjects enrolled should be 18 years of age or older.
  • •In France, patients enrolled into the renal impairment arm must be 18 years of age or older.
  • •Diagnosis of influenza (in Spain, Denmark and Germany: severe influenza requiring hospitalization) by virology testing or clinical diagnosis based on symptoms suggestive of influenza
  • •In Spain, Denmark and Germany: Hospitalized patients or requiring hospitalization and/or who are medically evaluated to not be good candidates for oral treatment and/or who might benefit from the IV administration of oseltamivir.
  • •Less than or equal to 144 hours between the onset of influenza-like illness and first dose of study medication
  • •Patient is willing and able to comply with study requirements and give consent, or, if applicable, consent may be given by a parent, legal guardian or legal representative
  • •Except in Spain, Denmark, and Germany: Patients who are pregnant may be enrolled only if the potential benefit justifies the potential risk to the fetus
  • •Except in Spain and Denmark: Patients who are lactating may be enrolled only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant. In Germany, patients who are
  • •lactating must also be unable to receive oral oseltamivir.
  • •In Spain and Denmark: Subjects who are in the reproductive age group and sexually active must agree to utilize and an effective method of contraception throughout the study period and for one reproductive cycle following cessation of the study therapy.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 11
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 149
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

  • •Patients with clinical evidence of severe hepatic decompensation at the time of randomization (e.g., evidence of jaundice, ascites, hepatic encephalopathy, and coagulation disturbances-Child-Pugh score above 9).
  • •Electrocardiogram showing acute ischemia or significant arrhythmia
  • •Allergy to test medication
  • •Patients taking probenicid medication within 7 days before starting study medication
  • •Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization (for renally impaired patients: 4 weeks prior to first dose of study medication).
  • •In Germany: Pregnant women
  • •In Spain and Denmark: Pregnant and lactating women

Investigators

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