Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells (FLUMED)
This study is currently recruiting participants.
Verified March 2012 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01546506
First received: March 2, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Influenza A Virus Infection |
Drug: Gutron® treatment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Midodrine hydrochloride
U.S. FDA Resources
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Comparison of viral replication kinetics between the 2 arms [ Time Frame: 7 days ] [ Designated as safety issue: No ]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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Frequency, duration and level of replication of the virus in nose samples [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Viral resistance and decrease of sensitivity of collected strains [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Tolerance of midodrine : incidence of adverse effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Side effects will be checked at each visit and reported for the entire study timeframe.
| Estimated Enrollment: | 161 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546506
Contacts
| Contact: Bruno LINA, MD, PhD | 472 12 96 17 ext +33 | bruno.lina@chu-lyon.fr |
| Contact: Ségolène GAILLARD | 427 85 77 28 ext +33 | segolene.gaillard@chu-lyon.fr |
Locations
| France | |
| Cabinet Médical du Dr ALIBERT | Recruiting |
| Bron, France, 69500 | |
| Contact: Delphine ALIBERT, MD | |
| Principal Investigator: Delphine ALIBERT, MD | |
| Centre d'Investigation Clinique de Lyon | Recruiting |
| Bron, France, 69677 | |
| Contact: Catherine CORNU, MD | |
| Contact: Ségolène GAILLARD | |
| Principal Investigator: Catherine CORNU, MD | |
| Cabinet Médical du Dr CURE | Recruiting |
| Bron, France, 69500 | |
| Contact: Nicole CURE, MD | |
| Principal Investigator: Nicole CURE, MD | |
| Cabinet Médical du Dr BUGEL | Recruiting |
| Lyon, France, 69006 | |
| Contact: Corinne BUGEL, MD | |
| Principal Investigator: Corinne BUGEL, MD | |
| Cabinet Médical du Dr CHAPDANIEL | Recruiting |
| Lyon, France, 69006 | |
| Contact: Christian CHAPDANIEL, MD | |
| Principal Investigator: Christian CHAPDANIEL, MD | |
| Cabinet Médical du Dr SAINT-OLIVE | Recruiting |
| Lyon, France, 69009 | |
| Contact: Dominique SAINT-OLIVE, MD | |
| Principal Investigator: Dominique SAINT-OLIVE, MD | |
| Cabinet Médical du Dr FORGEOIS | Recruiting |
| Lyon, France, 69005 | |
| Contact: Jacques FORGEOIS, MD | |
| Principal Investigator: Jacques FORGEOIS, MD | |
| Cabient Médical du Dr PIOS | Recruiting |
| Lyon, France, 69003 | |
| Contact: Renée PIOS | |
| Principal Investigator: Renée PIOS, MD | |
| Cabinet Médical du Dr HILLION | Recruiting |
| Lyon, France, 69001 | |
| Contact: Luc HILLION, MD | |
| Principal Investigator: Luc HILLION, MD | |
| Hôpital D'Instruction des Armées Desgenettes | Recruiting |
| Lyon, France, 69003 | |
| Contact: Christophe LABLANCHE, m | |
| Principal Investigator: Christophe LABLANCHE, MD | |
| Cabinet Médical du Dr TERRASSE | Recruiting |
| Lyon, France, 69005 | |
| Contact: Patrick TERRASSE, MD | |
| Principal Investigator: Patrick TERRASSE, MD | |
| Cbinet Médical du Dr CEZANNE-BERT | Recruiting |
| Saint Priest, France, 69800 | |
| Contact: Roland CEZANNE-BERT, MD | |
| Principal Investigator: Roland CEZANNE-BERT, MD | |
| Cabinet Médical du Dr SMIT | Recruiting |
| Saint-priest, France, 69800 | |
| Contact: Gérard SMIT, MD | |
| Principal Investigator: Gérard SMIT, MD | |
| Cabinet Médical du Dr DUBOIS | Recruiting |
| Saint-Symphorien d'Ozon, France, 69360 | |
| Contact: Jean-Pierre DUBOIS, MD | |
| Principal Investigator: Jean-Pierre DUBOIS, MD | |
| Cabinet Médical du Dr MARTIN | Recruiting |
| Venissieux, France, 69200 | |
| Contact: Xavier MARTIN, MD | |
| Principal Investigator: Xavier MARTIN, MD | |
| Cabinet Médical du Dr THEOULE | Recruiting |
| Venissieux, France, 69200 | |
| Contact: Jean THEOULE, MD | |
| Principal Investigator: Jean THEOULE, MD | |
| Cabinet Médical du Dr MOREAU | Recruiting |
| Villefontaine, France, 38090 | |
| Contact: Alain MOREAU, MD | |
| Principal Investigator: Alain MOREAU, MD | |
| Cabinet Médical du Dr BUFFLER | Recruiting |
| Villeurbanne, France, 69100 | |
| Contact: Philippe BUFFLER, MD | |
| Principal Investigator: Philippe BUFFLER, MD | |
| Cabinet Médical du Dr KESSOUS | Recruiting |
| Villeurbanne, France, 69100 | |
| Contact: Martine KESSOUS, MD | |
| Principal Investigator: Martine KESSOUS, MD | |
| Cabinet Médical du Dr PERDRIX | Recruiting |
| Villeurbanne, France, 69100 | |
| Contact: Corinne PERDRIX, MD | |
| Principal Investigator: Corinne PERDRIX, MD | |
| Cabinet Médical du Dr PILLARS | Recruiting |
| Villeurbanne, France, 69100 | |
| Contact: Michel PILLARS, MD | |
| Principal Investigator: Michel PILLARS, MD | |
| Cabinet Médical du Dr WEBER | Recruiting |
| Villeurbanne, France, 69100 | |
| Contact: Xavier-Jacques WEBER, MD | |
| Principal Investigator: Xavier-Jacques WEBER, MD | |
| Cabinet Médical du Dr MONLOUBOU | Recruiting |
| Villeurbanne, France, 69100 | |
| Contact: Damien MONLOUBOU, MD | |
| Principal Investigator: Damien MONLOUBOU, MD | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01546506 History of Changes |
| Other Study ID Numbers: | 2010.654/58 |
| Study First Received: | March 2, 2012 |
| Last Updated: | March 2, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Influenza, Human Virus Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Infections Respiratory Tract Diseases Antiviral Agents Midodrine Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013