FluPhase 2FLUNEXTNCT03212716
Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.
A Phase 2 study testing Oseltamivir and Diltiazem in people with Flu, run by University Hospital, Lille at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flu
- What is being tested?
- Oseltamivir and Diltiazem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 19 sitesFrance
- Study dates
- 23 Dec 2017to 4 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized in intensive care units,
- patients with mechanical ventilation invasive or non-invasive or Optiflow® ventilation system.
- for a suspicion of severe flu,
- with a symptoms for less than 96 hours,
- and a respiratory failure defined by the necessity to resort to mechanical ventilation, invasive or Optiflow® Ventilation System The inclusion is conditioned to the detection of Influenza A viruses by PCR on nasopharyngeal swab.
Who cannot join
- No consent.
- Hypersensibility to Oseltamivir
- Negative PCR on nasopharyngeal swab
- Symptoms for more than 96 hours.
- Moribund patients at inclusion.
- Pregnant/nursing woman.
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- Patients already taking diltiazem in the 48 hours before.
- Patients having taken more than 3 intakes of oseltamivir before randomization.
- Hemodynamic instability needing a dose of noradrenaline exceeding 2mg/h
- Contraindication to diltiazem:
- sinusal dysfunction without device.
- auriculo-ventricular heart block without device.
- Cardiogenic pulmonary oedema.
- Left cardiac failure
- bradycardia<40/min
- Concomitant use of beta-blockers, antiarrythmic drugs, especially amiodarone.
- Concomitant use of ivabradine, pimozide, nifedipine, ergot alkaloids.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Chu Amiens Picardie
Amiens
CH ARRAS
Arras
Ch Hnfc Site de Belfort
Belfort
Ch Bethune
Béthune
Ch Pierre Oudot Bourgoin Jallieu
Bourgoin
Chru Brest
Brest
CH DOUAI
Douai
Hôpital Raymond Poincaré
Garches
CH LENS
Lens
Hôpital Roger Salengro, CHRU
Lille
Hôpital Edouard Herriot Hospices Civils de Lyon
Lyon
CH de Montauban
Montauban
Ch Regional Orleans
Orléans
Gpe Hosp Cochin Saint Vincent de Paul - Paris
Paris
Hu Paris Sud Site Kremlin Bicetre Aphp
Paris
Hopitaux Universitaires de Strasbourg
Strasbourg
Hôpital Bretonneau
Tours
Ch de Valenciennes
Valenciennes
Centre Hospitalier de Versailles - Le Chesnay Rocquencourt
Versailles
About this study
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.
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.
- Conditions
- Flu
- Being tested
- Oseltamivir, Diltiazem, Placebos
- Keywords
- Infectiology, Biology of infectious agents, Flu, Intensive care
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
150 mg twice a day during 10 days (ANSM guidelines for severe flu).
DiltiazemDrug
60 mgx3 per day during 10 days.
PlacebosDrug
Placebo of diltiazem
| Study group | Role | What they receive |
|---|---|---|
| diltiazem | Experimental | oseltamivir + diltiazem Receives: Drug: Oseltamivir; Drug: Diltiazem |
| oseltamivir + placebo | Placebo comparator | oseltamivir + placebo of diltiazem Receives: Drug: Oseltamivir; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of alive patients without detection of influenza A virus by RT-PCR in nasopharyngeal swabs,
Measured: 7 days after the beginning of the treatment.
Secondary outcomes (7)
Delay needed for the negativation of influenza A detection by RT-PCR
Measured: up to 10days
Overall mortality
Measured: At 28 days
Length of mechanical ventilation
Measured: an average of 10 days
Change in Oxygenation (PaO2/FiO2 Ratio)
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.
Measured: once day for 10 days and at 28 days
Length of hospitalization
Measured: an average of 10 days in ICU and of 16 days in hospital
Length of extracorporeal membrane oxygenation (ECMO) if implemented.
Measured: an average of 10 days
Transcriptomic signature determined by the DNA microarray technology and analysed by bioinformatic tools
evaluation of the capacity of tested molecules to reverse the transcriptomic signature linked to the viral infection
Measured: Four time points : at inclusion, the first day after inclusion, the fourth day after inclusion, and the seventh day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start23 Dec 2017
- Primary completion4 May 2022
- Study completion4 May 2022
Why it stopped: rate of inclusion and study affected by covid-19 epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Julien Poissy, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212716
- Sponsor's protocol ID
- 2015_65
- Other IDs
- 2016-004222-42, PHRC_N -15-0442, 2016
- Acronym
- FLUNEXT
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2017
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03212716
- Acronym / sponsor ID
- FLUNEXT / 2015_65
- Conditions
- Flu
- Keywords
- Infectiology, Biology of infectious agents, Flu, Intensive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: rate of inclusion and study affected by covid-19 epidemic
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diltiazem | Experimental | Drug: Oseltamivir, Drug: Diltiazemoseltamivir + diltiazem |
| oseltamivir + placebo | Placebo comparator | Drug: Oseltamivir, Drug: Placebososeltamivir + placebo of diltiazem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients hospitalized in intensive care units,
- patients with mechanical ventilation invasive or non-invasive or Optiflow® ventilation system.
- for a suspicion of severe flu,
- with a symptoms for less than 96 hours,
- and a respiratory failure defined by the necessity to resort to mechanical ventilation, invasive or Optiflow® Ventilation System The inclusion is conditioned to the detection of Influenza A viruses by PCR on nasopharyngeal swab.
Key exclusion criteria (17 listed)
- No consent.
- Hypersensibility to Oseltamivir
- Negative PCR on nasopharyngeal swab
- Symptoms for more than 96 hours.
- Moribund patients at inclusion.
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 |
|---|---|---|
| Oseltamivir150 mg twice a day during 10 days (ANSM guidelines for severe flu). | Drug | diltiazem, oseltamivir + placebo |
| Diltiazem60 mgx3 per day during 10 days. | Drug | diltiazem |
| PlacebosPlacebo of diltiazem | Drug | oseltamivir + placebo |
Primary outcome
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.
7 secondary outcomes
Delay needed for the negativation of influenza A detection by RT-PCR
Time frame: up to 10days
Overall mortality
Time frame: At 28 days
Length of mechanical ventilation
Time frame: an average of 10 days
Change in Oxygenation (PaO2/FiO2 Ratio)
Time frame: once day for 10 days and at 28 days
Length of hospitalization
Time frame: an average of 10 days in ICU and of 16 days in hospital
Length of extracorporeal membrane oxygenation (ECMO) if implemented.
Time frame: an average of 10 days
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
Results and safety
The study was stopped early (reason given: rate of inclusion and study affected by covid-19 epidemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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.
Julien Poissy, MD, PhD principal investigator
University Hospital, Lille
19 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 Oseltamivir and Diltiazem in people with Flu, run by University Hospital, Lille at 19 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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: rate of inclusion and study affected by covid-19 epidemic). Results are not available in the source record.
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?
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.). 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 6 Feb 2023.