Influenza A Virus Infection Clinical Trial
Official title:
Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
Rationale:
Classical antiviral therapies target viral proteins and are consequently subject to
resistance. To counteract this limitation, alternative strategies have been developed that
target cellular factors. We hypothesized that such an approach could also be useful to
identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral
diversity and because of the need to develop therapies against unpredictable viruses as
recently underlined by the H1N1 pandemic. Gene-expression signature-based screening
identified broadly effective influenza A antivirals. Midodrine showed great results in
inhibiting viral growth and was the most suited to confirm its efficacy in vivo.
The main objective of the study is to assess the efficacy of midodrine taken at usual
recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus
Influenza A.
Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3
5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as
the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of
midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic
of viral replication; analysis of the frequency of emergence of mutants and associated
resistance.
Methods:
This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years
infected by influenza A virus. Nasopharyngeal washing will be performed at day 0
(randomization), 2, 3, 5 to show the viral replication evolution.
161 patients will be randomized as follows :
- Arm 1 : Midodrine, 2.5 mg, 3 times a day
- Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon
area.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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