Influenza A Virus InfectionPhase 2FLUMEDNCT01546506
Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
A Phase 2 study testing Gutron® treatment in people with Influenza A Virus Infection, run by Hospices Civils de Lyon at 39 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza A Virus Infection
- What is being tested?
- Gutron® treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 39 sitesFrance
- Study dates
- Feb 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
France39 sites
Cabinet Médical du Dr ALIBERT
Bron, 69500
Cabinet Médical du Dr CURE
Bron, 69500
Centre d'Investigation Clinique de Lyon
Bron, 69677
Cabinet du Dr DAHAN
Decine Charpieu, 69150
Cabinet du Dr MADELON
Décine Charpieu, 69150
Cabinet Médical du Dr HILLION
Lyon, 69001
Cabient Médical du Dr PIOS
Lyon, 69003
Cabinet du Dr ATTALI
Lyon, 69003
Cabinet du Dr COUTY
Lyon, 69003
Hôpital D'Instruction des Armées Desgenettes
Lyon, 69003
Cabinet Médical du Dr FORGEOIS
Lyon, 69005
Cabinet Médical du Dr TERRASSE
Lyon, 69005
Cabinet du Dr THIBAUT
Lyon, 69006
Cabinet Médical du Dr BUGEL
Lyon, 69006
Cabinet Médical du Dr CHAPDANIEL
Lyon, 69006
Cabinet du Dr AKIKI
Lyon, 69007
Cabinet du Dr BOURAS
Lyon, 69007
Cabinet du Dr GREVE
Lyon, 69007
Cabinet du Dr MANOELIAN
Lyon, 69007
Cabinet du Dr ROCHE
Lyon, 69007
Cabinet du Dr AZULAY TEBOUL
Lyon, 69009
Cabinet du Dr DRUT
Lyon, 69009
Cabinet Médical du Dr SAINT-OLIVE
Lyon, 69009
Cabinet du Dr JACQUET
Meyzieu, 69330
Cabinet du Dr FARHAT
Saint-Pierre-de-Chandieu, 69780
Cabinet du Dr CHAMPETIER
Saint-Priest, 69800
Cabinet Médical du Dr SMIT
Saint-Priest, 69800
Cbinet Médical du Dr CEZANNE-BERT
Saint-Priest, 69800
Cabinet Médical du Dr DUBOIS
Saint-Symphorien-dOzon, 69360
Cabinet du Dr CHAIZE
Vénissieux, 69200
Cabinet Médical du Dr MARTIN
Vénissieux, 69200
Cabinet Médical du Dr THEOULE
Vénissieux, 69200
Cabinet Médical du Dr MOREAU
Villefontaine, 38090
Cabinet Médical du Dr BUFFLER
Villeurbanne, 69100
Cabinet Médical du Dr KESSOUS
Villeurbanne, 69100
Cabinet Médical du Dr MONLOUBOU
Villeurbanne, 69100
Cabinet Médical du Dr PERDRIX
Villeurbanne, 69100
Cabinet Médical du Dr PILLARS
Villeurbanne, 69100
Cabinet Médical du Dr WEBER
Villeurbanne, 69100
About this study
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.
Read more
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.
- Conditions
- Influenza A Virus Infection
- Being tested
- Gutron® treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gutron® treatmentDrug
Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Midodrine | Experimental | Midodrine 2.5 mg orally 3 times daily, 5 day-treatment. Receives: Drug: Gutron® treatment |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (5)
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
Measured: 7 days
Duration and severity of flu symptoms
Measured: 7 days
Frequency, duration and level of replication of the virus in nose samples
Measured: 7 days
Viral resistance and decrease of sensitivity of collected strains
Measured: 7 days
Tolerance of midodrine : incidence of adverse effects
Side effects will be checked at each visit and reported for the entire study timeframe.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Virus InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LINA, MD, PhD, Principal investigator, Laboratoire de virologie, Institut de microbiologie, Centre de Biologie et de Pathologie EST, Groupement Hospitalier Est, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546506
- Sponsor's protocol ID
- 2010.654/58
- Acronym
- FLUMED
- Status last verified
- Jan 2015
- First submitted
- 2 Mar 2012
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
- ClinicalTrials.gov ID
- NCT01546506
- Acronym / sponsor ID
- FLUMED / 2010.654/58
- Conditions
- Influenza A Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine | Experimental | Drug: Gutron® treatmentMidodrine 2.5 mg orally 3 times daily, 5 day-treatment. |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (28 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gutron® treatmentMidodrine 2.5 mg orally 3 times daily, 5 day-treatment. | Drug | Midodrine |
Primary outcome
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
5 secondary outcomes
Percentage of patients with a normalized viral load
Time frame: 7 days
Duration and severity of flu symptoms
Time frame: 7 days
Frequency, duration and level of replication of the virus in nose samples
Time frame: 7 days
Viral resistance and decrease of sensitivity of collected strains
Time frame: 7 days
Tolerance of midodrine : incidence of adverse effects
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno LINA, MD, PhD principal investigator
Laboratoire de virologie, Institut de microbiologie, Centre de Biologie et de Pathologie EST, Groupement Hospitalier Est, Hospices Civils de Lyon
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gutron® treatment in people with Influenza A Virus Infection, run by Hospices Civils de Lyon at 39 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of viral replication kinetics between the 2 arms (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.