Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.
NCT ID: NCT03212716
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
85 participants
INTERVENTIONAL
2017-12-23
2022-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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diltiazem
oseltamivir + diltiazem
Oseltamivir
150 mg twice a day during 10 days (ANSM guidelines for severe flu).
Diltiazem
60 mgx3 per day during 10 days.
oseltamivir + placebo
oseltamivir + placebo of diltiazem
Oseltamivir
150 mg twice a day during 10 days (ANSM guidelines for severe flu).
Placebos
Placebo of diltiazem
Interventions
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Oseltamivir
150 mg twice a day during 10 days (ANSM guidelines for severe flu).
Diltiazem
60 mgx3 per day during 10 days.
Placebos
Placebo of diltiazem
Eligibility Criteria
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Inclusion Criteria
* 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,
* and a respiratory failure defined by the necessity to resort to mechanical ventilation, invasive or Optiflow® Ventilation System The inclusion is conditioned to the detection of Influenza A viruses by PCR on nasopharyngeal swab.
Exclusion Criteria
* Hypersensibility to Oseltamivir
* Negative PCR on nasopharyngeal swab
* Symptoms for more than 96 hours.
* Moribund patients at inclusion.
* 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.
* Concomitant use of ivabradine, pimozide, nifedipine, ergot alkaloids.
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Julien Poissy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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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
Countries
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Other Identifiers
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2016-004222-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHRC_N -15-0442
Identifier Type: OTHER
Identifier Source: secondary_id
2015_65
Identifier Type: -
Identifier Source: org_study_id
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