Influenza Clinical Trial
Official title:
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung diseases that make them particularly at risk of severe influenza infections that may result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu, but there are still many hospitalizations, complications, and deaths even with treatment. This study evaluated the use of combination antivirals (amantadine, oseltamivir, and ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk population.
Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually
and despite effective antivirals causes significant morbidity and mortality (estimated
24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged
in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the
U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1
occurred among people younger than 65 years of age. The CDC has defined an at-risk population
that accounts for the majority of hospitalization and morbidity associated with influenza.
This study evaluated the use of combination antivirals as compared to oseltamivir alone in
the treatment of influenza in an at-risk population.
Subjects who met the CDC definition for being at-risk and that present with an influenza-like
illness were screened for the study. Those subjects with a confirmatory test for influenza
(rapid antigen or PCR) were randomized in a 1:1 manner to receive a blinded study treatment
consisting of either the combination of amantadine, oseltamivir, and ribavirin or oseltamivir
alone for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, 14, and 28
were used for both safety and efficacy analysis.
Design:
- Participants were screened with a physical examination and medical history, along with
blood tests and throat swabs to confirm influenza infection.
- Eligible participants were randomly assigned to take either oseltamivir alone (the
current standard treatment for influenza) or to take oseltamivir, amantadine, and
ribavirin. Participants had additional blood samples and throat swabs taken at the start
of the study, and were shown how to complete a study diary at home.
- Participants received a study medication kit containing the medication to take at home
twice a day for 5 days.
- Participants returned, with the medication kit, to the clinic on days 1 (the first day
after the start of the study), 3, 7, 14, and 28. The first visit took 2 to 3 hours, but
each subsequent visit took approximately 1 to 2 hours. Additional blood samples and
throat swabs were taken at these visits.
Pilot study:
Due to the lack of reliable data concerning the AUC virologic endpoint, an "external" pilot
study was conducted in the first 47 patients randomized to identify a primary endpoint and
method of analysis, and to possibly modify the sample size. To ensure no effect on the type I
error rate, data from these 47 patients were excluded from the primary and secondary efficacy
analyses but were used in other analyses of secondary objectives.
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