Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection. (FLUNEXT)

University Hospital, Lille

Status and phase: Terminated; Phase 2

Conditions: Flu

Treatments: Drug: Oseltamivir; Drug: Diltiazem; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03212716

2015_65

PHRC_N -15-0442 (Other Identifier)

2016-004222-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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,
• 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

• No consent.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups, including a placebo group

diltiazem

Experimental group

Description:

oseltamivir + diltiazem

Treatment:

Drug: Oseltamivir

Drug: Diltiazem

oseltamivir + placebo

Placebo Comparator group

Description:

oseltamivir + placebo of diltiazem

Treatment:

Drug: Placebos

Drug: Oseltamivir