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Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.
FLUNEXT
Validation of the Efficiency of Molecules Reproposed on the Basis of Their Cellular Transcriptomic Signature, Antagonist of the Signature Determined in Infection Due to Virus Influenza A.
3 other identifiers
interventional
85
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2017
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
December 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2022
CompletedFebruary 6, 2023
January 1, 2023
4.4 years
July 4, 2017
February 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of alive patients without detection of influenza A virus by RT-PCR in nasopharyngeal swabs,
7 days after the beginning of the treatment.
Secondary Outcomes (7)
Delay needed for the negativation of influenza A detection by RT-PCR
up to 10days
Overall mortality
At 28 days
Length of mechanical ventilation
an average of 10 days
Change in Oxygenation (PaO2/FiO2 Ratio)
once day for 10 days and at 28 days
Length of hospitalization
an average of 10 days in ICU and of 16 days in hospital
- +2 more secondary outcomes
Study Arms (2)
diltiazem
EXPERIMENTALoseltamivir + diltiazem
oseltamivir + placebo
PLACEBO COMPARATORoseltamivir + placebo of diltiazem
Interventions
150 mg twice a day during 10 days (ANSM guidelines for severe flu).
Eligibility Criteria
You may qualify if:
- patients hospitalized in intensive care units,
- patients with mechanical ventilation invasive or non-invasive or Optiflow® ventilation system.
- for a suspicion of severe flu,
- with a symptoms for less than 96 hours,
You may not qualify if:
- No consent.
- Hypersensibility to Oseltamivir
- Negative PCR on nasopharyngeal swab
- Symptoms for more than 96 hours.
- Pregnant/nursing woman.
- Patients already taking diltiazem in the 48 hours before.
- Patients having taken more than 3 intakes of oseltamivir before randomization.
- Hemodynamic instability needing a dose of noradrenaline exceeding 2mg/h
- Contraindication to diltiazem:
- sinusal dysfunction without device.
- auriculo-ventricular heart block without device.
- Cardiogenic pulmonary oedema.
- Left cardiac failure
- bradycardia\<40/min
- Concomitant use of beta-blockers, antiarrythmic drugs, especially amiodarone.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Ministry of Health, Francecollaborator
Study Sites (19)
Chu Amiens Picardie
Amiens, France
CH ARRAS
Arras, France
Ch Hnfc Site de Belfort
Belfort, France
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
Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon, France
CH de Montauban
Montauban, France
Ch Regional Orleans
Orléans, France
Gpe Hosp Cochin Saint Vincent de Paul - Paris
Paris, France
Hu Paris Sud Site Kremlin Bicetre Aphp
Paris, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Hôpital Bretonneau
Tours, France
Ch de Valenciennes
Valenciennes, France
Centre Hospitalier de Versailles - Le Chesnay Rocquencourt
Versailles, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien Poissy, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2017
First Posted
July 11, 2017
Study Start
December 23, 2017
Primary Completion
May 4, 2022
Study Completion
May 4, 2022
Last Updated
February 6, 2023
Record last verified: 2023-01