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Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells (FLUMED)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01546506
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Rationale:

Classical antiviral therapies target viral proteins and are consequently subject to resistance. To counteract this limitation, alternative strategies have been developed that target cellular factors. We hypothesized that such an approach could also be useful to identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral diversity and because of the need to develop therapies against unpredictable viruses as recently underlined by the H1N1 pandemic. Gene-expression signature-based screening identified broadly effective influenza A antivirals. Midodrine showed great results in inhibiting viral growth and was the most suited to confirm its efficacy in vivo.

The main objective of the study is to assess the efficacy of midodrine taken at usual recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus Influenza A.

Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3 5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic of viral replication; analysis of the frequency of emergence of mutants and associated resistance.

Methods:

This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years infected by influenza A virus. Nasopharyngeal washing will be performed at day 0 (randomization), 2, 3, 5 to show the viral replication evolution.

161 patients will be randomized as follows :

  • Arm 1 : Midodrine, 2.5 mg, 3 times a day
  • Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon area.

Condition or disease Intervention/treatment Phase
Influenza A Virus Infection Drug: Gutron® treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
Study Start Date : February 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Midodrine
Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
Drug: Gutron® treatment
Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.

No Intervention: No treatment



Primary Outcome Measures :
  1. Comparison of viral replication kinetics between the 2 arms [ Time Frame: 7 days ]
    Comparison of the viral load slopes for 7 days post-study treatment start. Viral load will be measured at day 0, 2, 3, 5, and 7


Secondary Outcome Measures :
  1. Percentage of patients with a normalized viral load [ Time Frame: 7 days ]
    A normal viral load is defined as a value below the positive threshold of 3 in RT-qPCR at day 2, 3, 5 and 7

  2. Duration and severity of flu symptoms [ Time Frame: 7 days ]
  3. Frequency, duration and level of replication of the virus in nose samples [ Time Frame: 7 days ]
  4. Viral resistance and decrease of sensitivity of collected strains [ Time Frame: 7 days ]
  5. Tolerance of midodrine : incidence of adverse effects [ Time Frame: 7 days ]
    Side effects will be checked at each visit and reported for the entire study timeframe.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women aged 18 to 65 years,
  • with no long-term illness,
  • presenting flu-like symptoms for less than 42 hours (nasal congestion, sore throat, muscle soreness, asthenia, headache, chills/sweating, fever…),
  • infection with influenza A virus confirmed with a quick diagnostic test,
  • outpatient care,
  • must provide signed and informed consent,
  • beneficiary of a health insurance.

Exclusion Criteria:

  • severe form of flu,
  • pregnant women or positive pregnancy test,
  • breastfeeding women,
  • women of childbearing-potential with no efficient contraceptive,
  • history of chronic respiratory disease : asthma or chronic obstructive pulmonary disease,
  • renal failure,
  • Raynaud's disease,
  • history of epilepsy, confusion, hallucinations or of psychoneurotic state,
  • patients with an increased cardiovascular risk (> 20% according to the Framingham scale) or with a cardiovascular history,
  • patients having a congestive heart failure, swollen legs or a posture hypotension,
  • patients who received a influenza vaccine for seasons 2011-2012 or 2012-2013,
  • known hypersensitivity to any component of the treatment,
  • topical use of nasal decongestant (except physiological serum),
  • use of steroids, immunosuppressive or antipsychotics drugs (including treatments for nausea),
  • use of indirect sympathomimetics drugs (ephedrine, methylphenidate, phenylephrine, pseudoephedrine),
  • use of dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride, pergolide) or vasoconstrictor ergot alkaloids (dihydroergotamine, ergotamine, methylergométrine, methylsergide),
  • known hypertension treated or not,
  • history of bradycardia,
  • history of urinary retention,
  • severe cardiopathy,
  • acute angle-closure glaucoma,
  • severe obliterative vasculopathy,
  • vasospasm,
  • thyrotoxicosis,
  • pheochromocytoma,
  • history of angina pectoris,
  • use of guanethidine and related, iproniazide (non selective MAOIs), alpha-blockers and digitalis drugs
  • use of neuraminidase inhibitors: oseltamivir, zanamivir; and M2 proton-selective ion channel inhibitors: amantadine and rimantadine

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): NCT01546506


Locations
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Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Bruno LINA, MD, PhD Laboratoire de virologie, Institut de microbiologie, Centre de Biologie et de Pathologie EST, Groupement Hospitalier Est, Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01546506    
Other Study ID Numbers: 2010.654/58
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Virus Diseases
Antiviral Agents
Midodrine
Anti-Infective Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action