Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03212716
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Flu Drug: Oseltamivir Drug: Diltiazem Drug: Placebos Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : December 23, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: diltiazem
oseltamivir + diltiazem
Drug: Oseltamivir
150 mg twice a day during 10 days (ANSM guidelines for severe flu).

Drug: Diltiazem
60 mgx3 per day during 10 days.

Placebo Comparator: oseltamivir + placebo
oseltamivir + placebo of diltiazem
Drug: Oseltamivir
150 mg twice a day during 10 days (ANSM guidelines for severe flu).

Drug: Placebos
Placebo of diltiazem




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Delay needed for the negativation of influenza A detection by RT-PCR [ Time Frame: up to 10days ]
  2. Overall mortality [ Time Frame: At 28 days ]
  3. Length of mechanical ventilation [ Time Frame: an average of 10 days ]
  4. 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.

  5. Length of hospitalization [ Time Frame: an average of 10 days in ICU and of 16 days in hospital ]
  6. Length of extracorporeal membrane oxygenation (ECMO) if implemented. [ Time Frame: an average of 10 days ]
  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients hospitalized in intensive care units,
  • for a suspicion of severe flu,
  • with a pneumonia for less than 96 hours,
  • and a respiratory failure defined by the necessity to resort to mechanical ventilation, invasive or not, or to deliver oxygen with a PaO2/FiO2<200 mmHg.

The inclusion is conditioned to the detection of Influenza A viruses rapid detection kit on nasopharyngeal swab.

Exclusion Criteria:

  • No consent.
  • Hypersensibility to Oseltamivir
  • Negative rapid detection kit on nasopharyngeal swab.
  • Symptoms for more than 96 hours.
  • Moribund patients at inclusion.
  • Pregnant/nursing woman.
  • Patients already taking diltiazem in their personal home treatment.
  • Patients having taken more than 3 intakes of oseltamivir before randomization.

Contraindication to diltiazem:

  • sinusal dysfonction without device.
  • auriculo-ventricular heart block without device.
  • Cardiogenic pulmonary oedema.
  • Left cardiac failure
  • bradycardia<40/min
  • Concomitant use of beta-blockers, antiarythmic drugs, especially amiodarone.
  • Concomitant use of ivabradine, pimozide, nifedipine, ergot alkaloids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212716


Contacts
Layout table for location contacts
Contact: Julien Poissy, MD, PhD 03 20 44 44 95 ext +33 julien.poissy@chru-lille.fr

Locations
Layout table for location information
France
Hôpital Raymond Poincaré Recruiting
Garches, France
Principal Investigator: Djillali Annane, MD         
Hôpital Roger Salengro, CHRU Recruiting
Lille, France
Principal Investigator: Julien Poissy, MD         
Hôpital Edouard Herriot Hospices Civils de Lyon Recruiting
Lyon, France
Principal Investigator: Thomas Rimmelé, MD         
CH de Montauban Recruiting
Montauban, France
Principal Investigator: Sylvie Vimeux, MD         
Hôpital Bretonneau Recruiting
Tours, France
Principal Investigator: Denis Garot, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Layout table for investigator information
Principal Investigator: Julien Poissy, MD, PhD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03212716     History of Changes
Other Study ID Numbers: 2015_65
2016-004222-42 ( EudraCT Number )
PHRC_N -15-0442 ( Other Identifier: PHRC number )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Infectiology
Biology of infectious agents
Flu
Intensive care

Additional relevant MeSH terms:
Layout table for MeSH terms
Oseltamivir
Diltiazem
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents