Active and standard of care for Influenza

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
InfluenzaOseltamivir - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study whether a combination of two drugs is more effective than one drug at treating influenza in stem cell transplant patients.

Eligible Conditions
  • Influenza

Treatment Effectiveness

Study Objectives

7 Primary · 12 Secondary · Reporting Duration: Baseline; Day 4; Day 7; Day 10

Baseline to Day 30
Therapeutic procedure
Percentage of patients with treatment-emergent variants of neuraminidase and polymerase by direct next-generation sequencing
Time to improvement of individual influenza symptoms as assessed by patient-reported outcome measures on a single scale
Time to viral clearance, as assessed by difference in Percentage of Participants Positive by RT-PCR at each time-point (in each treatment group)
Time to viral clearance, as assessed by difference in Percentage of Participants Positive by influenza plaque assay at each time-point (in each treatment group)
Time to viral clearance, as assessed by difference in Percentage of Participants Positive by quantitative real time polymerase chain reaction
Time to viral clearance, as assessed by time to sustained Cessation of Viral detection by RT-PCR up to day 30 defined as the time between the start of treatment and when virus titer will be below the detection limit on all subsequent sampling time points
Baseline; Day 10
Between-treatment-arm difference in the change of influenza viral RNA loads from baseline at the end of treatment as measured by influenza plaque assay (replicating virus).
Between-treatment-arm difference in the change of influenza viral RNA loads from baseline at the end of treatment as measured by quantitative real time polymerase chain reaction.
Change of influenza viral RNA loads from baseline at the end of treatment as measured by quantitative real time polymerase chain reaction.
Orthomyxoviridae
Change of influenza viral load from baseline at the end of treatment as assessed by the change of the amount of influenza virus at day 10 measured by quantitative real time polymerase chain reaction (qRT-PCR, nucleic acid)
Day 10
Change of influenza viral RNA load from baseline at day 4 and day 7 and 10 in each treatment arm
Change of influenza viral loads from baseline at day 4, 7 and 10 as measured by influenza plaque assay (replicating virus) in each treatment arm
Difference in change of influenza viral loads from baseline at day 4, 7 and 10 between the two treatment arms as measured by influenza plaque assay (replicating virus)
Difference in change of influenza viral loads from baseline at day 4, 7 and 10 between the two treatment arms as measured by quantitative real time polymerase chain reaction
Day 15
Percentage of participants with adverse events (AEs)
Day 30
Percentage of patients who experience each influenza-related complications: hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia as an adverse event after the initiation of study treatment
Time to return to preinfluenza health status

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Active and standard of care
1 of 2
Placebo and standard of care
1 of 2

Active Control

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Active and standard of care · Has Placebo Group · Phase 2 & 3

Active and standard of careActiveComparator Group · 2 Interventions: Oseltamivir, Baloxavir Marboxil · Intervention Types: Drug, Drug
Placebo and standard of carePlaceboComparator Group · 2 Interventions: Oseltamivir, Placebo · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; day 4; day 7; day 10

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
986 Previous Clinical Trials
1,338,542 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,497 Previous Clinical Trials
564,586 Total Patients Enrolled
Mirella Salvatore, MDPrincipal InvestigatorWeill Medical College of Cornell University

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to comply with the study protocol.
You have received allogeneic bone marrow transplant.
References