Back to resultsConfirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells (FLUMED)
Primary Purpose
Influenza A Virus Infection
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gutron® treatment
Sponsored by
About this trial
This is an interventional treatment trial for Influenza A Virus Infection
Eligibility 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
Sites / Locations
- Cabinet Médical du Dr ALIBERT
- Cabinet Médical du Dr CURE
- Centre d'Investigation Clinique de Lyon
- Cabinet du Dr DAHAN
- Cabinet du Dr MADELON
- Cabinet Médical du Dr HILLION
- Cabient Médical du Dr PIOS
- Cabinet du Dr ATTALI
- Cabinet du Dr COUTY
- Hôpital D'Instruction des Armées Desgenettes
- Cabinet Médical du Dr FORGEOIS
- Cabinet Médical du Dr TERRASSE
- Cabinet du Dr THIBAUT
- Cabinet Médical du Dr BUGEL
- Cabinet Médical du Dr CHAPDANIEL
- Cabinet du Dr AKIKI
- Cabinet du Dr BOURAS
- Cabinet du Dr GREVE
- Cabinet du Dr MANOELIAN
- Cabinet du Dr ROCHE
- Cabinet du Dr AZULAY TEBOUL
- Cabinet du Dr DRUT
- Cabinet Médical du Dr SAINT-OLIVE
- Cabinet du Dr JACQUET
- Cabinet du Dr CHAMPETIER
- Cbinet Médical du Dr CEZANNE-BERT
- Cabinet Médical du Dr SMIT
- Cabinet Médical du Dr DUBOIS
- Cabinet du Dr FARHAT
- Cabinet du Dr CHAIZE
- Cabinet Médical du Dr MARTIN
- Cabinet Médical du Dr THEOULE
- Cabinet Médical du Dr MOREAU
- Cabinet Médical du Dr BUFFLER
- Cabinet Médical du Dr KESSOUS
- Cabinet Médical du Dr MONLOUBOU
- Cabinet Médical du Dr PERDRIX
- Cabinet Médical du Dr PILLARS
- Cabinet Médical du Dr WEBER
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Midodrine
No treatment
Arm Description
Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
Outcomes
Primary Outcome Measures
Comparison of viral replication kinetics between the 2 arms
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
Percentage of patients with a normalized viral load
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
Duration and severity of flu symptoms
Frequency, duration and level of replication of the virus in nose samples
Viral resistance and decrease of sensitivity of collected strains
Tolerance of midodrine : incidence of adverse effects
Side effects will be checked at each visit and reported for the entire study timeframe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01546506
Brief Title
Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
Acronym
FLUMED
Official Title
Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midodrine
Arm Type
Experimental
Arm Description
Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Gutron® treatment
Intervention Description
Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
Primary Outcome Measure Information:
Title
Comparison of viral replication kinetics between the 2 arms
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Percentage of patients with a normalized viral load
Description
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
Time Frame
7 days
Title
Duration and severity of flu symptoms
Time Frame
7 days
Title
Frequency, duration and level of replication of the virus in nose samples
Time Frame
7 days
Title
Viral resistance and decrease of sensitivity of collected strains
Time Frame
7 days
Title
Tolerance of midodrine : incidence of adverse effects
Description
Side effects will be checked at each visit and reported for the entire study timeframe.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno LINA, MD, PhD
Organizational Affiliation
Laboratoire de virologie, Institut de microbiologie, Centre de Biologie et de Pathologie EST, Groupement Hospitalier Est, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet Médical du Dr ALIBERT
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Cabinet Médical du Dr CURE
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Centre d'Investigation Clinique de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Cabinet du Dr DAHAN
City
Decine Charpieu
ZIP/Postal Code
69150
Country
France
Facility Name
Cabinet du Dr MADELON
City
Décine Charpieu
ZIP/Postal Code
69150
Country
France
Facility Name
Cabinet Médical du Dr HILLION
City
Lyon
ZIP/Postal Code
69001
Country
France
Facility Name
Cabient Médical du Dr PIOS
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Cabinet du Dr ATTALI
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Cabinet du Dr COUTY
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hôpital D'Instruction des Armées Desgenettes
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Cabinet Médical du Dr FORGEOIS
City
Lyon
ZIP/Postal Code
69005
Country
France
Facility Name
Cabinet Médical du Dr TERRASSE
City
Lyon
ZIP/Postal Code
69005
Country
France
Facility Name
Cabinet du Dr THIBAUT
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Cabinet Médical du Dr BUGEL
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Cabinet Médical du Dr CHAPDANIEL
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Cabinet du Dr AKIKI
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Cabinet du Dr BOURAS
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Cabinet du Dr GREVE
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Cabinet du Dr MANOELIAN
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Cabinet du Dr ROCHE
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Cabinet du Dr AZULAY TEBOUL
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
Cabinet du Dr DRUT
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
Cabinet Médical du Dr SAINT-OLIVE
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
Cabinet du Dr JACQUET
City
Meyzieu
ZIP/Postal Code
69330
Country
France
Facility Name
Cabinet du Dr CHAMPETIER
City
Saint Priest
ZIP/Postal Code
69800
Country
France
Facility Name
Cbinet Médical du Dr CEZANNE-BERT
City
Saint Priest
ZIP/Postal Code
69800
Country
France
Facility Name
Cabinet Médical du Dr SMIT
City
Saint-priest
ZIP/Postal Code
69800
Country
France
Facility Name
Cabinet Médical du Dr DUBOIS
City
Saint-Symphorien d'Ozon
ZIP/Postal Code
69360
Country
France
Facility Name
Cabinet du Dr FARHAT
City
St Pierre de Chandieu
ZIP/Postal Code
69780
Country
France
Facility Name
Cabinet du Dr CHAIZE
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Cabinet Médical du Dr MARTIN
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Cabinet Médical du Dr THEOULE
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Cabinet Médical du Dr MOREAU
City
Villefontaine
ZIP/Postal Code
38090
Country
France
Facility Name
Cabinet Médical du Dr BUFFLER
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Cabinet Médical du Dr KESSOUS
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Cabinet Médical du Dr MONLOUBOU
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Cabinet Médical du Dr PERDRIX
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Cabinet Médical du Dr PILLARS
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Cabinet Médical du Dr WEBER
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
12. IPD Sharing Statement
Learn more about this trial
Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
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