The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral ones, based on their ability to reverse the transcriptomic signature of the infected cells. This strategy has to be considered is the context of emerging viral diseases and of increase of resistance to antivirals. Concerning infection by Influenza viruses, the main drugs were identified and evaluated on in vitro and in vivo models: diltiazem. Therefore, it will be assess the efficacy of these the drug, compared to placebo, to treat severe flu.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
85
150 mg twice a day during 10 days (ANSM guidelines for severe flu).
60 mgx3 per day during 10 days.
Placebo of diltiazem
Chu Amiens Picardie
Amiens, France
CH ARRAS
Arras, France
Ch Hnfc Site de Belfort
Belfort, France
Percentage of alive patients without detection of influenza A virus by RT-PCR in nasopharyngeal swabs,
Time frame: 7 days after the beginning of the treatment.
Delay needed for the negativation of influenza A detection by RT-PCR
Time frame: up to 10days
Overall mortality
Time frame: At 28 days
Length of mechanical ventilation
Time frame: an average of 10 days
Change in Oxygenation (PaO2/FiO2 Ratio)
Arterial blood samples for blood gas analysis are collected during the treatment period. The differences in the mean values of PaO2/FiO2 ratio are registered and analysed.
Time frame: once day for 10 days and at 28 days
Length of hospitalization
Time frame: an average of 10 days in ICU and of 16 days in hospital
Length of extracorporeal membrane oxygenation (ECMO) if implemented.
Time frame: an average of 10 days
Transcriptomic signature determined by the DNA microarray technology and analysed by bioinformatic tools
evaluation of the capacity of tested molecules to reverse the transcriptomic signature linked to the viral infection
Time frame: Four time points : at inclusion, the first day after inclusion, the fourth day after inclusion, and the seventh day after inclusion
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Ch Bethune
Béthune, France
Ch Pierre Oudot Bourgoin Jallieu
Bourgoin, France
Chru Brest
Brest, France
CH DOUAI
Douai, France
Hôpital Raymond Poincaré
Garches, France
CH LENS
Lens, France
Hôpital Roger Salengro, CHRU
Lille, France
...and 9 more locations