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

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ClinicalTrials.gov Identifier: NCT03212716
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date November 20, 2020
Actual Study Start Date  ICMJE December 23, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • 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) [ Time Frame: once day for 10 days and at 28 days ]
    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.
  • 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 [ Time Frame: Four time points : at inclusion, the first day after inclusion, the fourth day after inclusion, and the seventh day after inclusion ]
    evaluation of the capacity of tested molecules to reverse the transcriptomic signature linked to the viral infection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Flu
Intervention  ICMJE
  • Drug: Oseltamivir
    150 mg twice a day during 10 days (ANSM guidelines for severe flu).
  • Drug: Diltiazem
    60 mgx3 per day during 10 days.
  • Drug: Placebos
    Placebo of diltiazem
Study Arms  ICMJE
  • Experimental: diltiazem
    oseltamivir + diltiazem
    Interventions:
    • Drug: Oseltamivir
    • Drug: Diltiazem
  • Placebo Comparator: oseltamivir + placebo
    oseltamivir + placebo of diltiazem
    Interventions:
    • Drug: Oseltamivir
    • Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julien Poissy, MD, PhD 03 20 44 44 95 ext +33 julien.poissy@chru-lille.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03212716
Other Study ID Numbers  ICMJE 2015_65
2016-004222-42 ( EudraCT Number )
PHRC_N -15-0442 ( Other Identifier: PHRC number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Julien Poissy, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP