Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infe… (NCT03212716) | Clinical Trial Compass
TerminatedPhase 2
Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.
Stopped: rate of inclusion and study affected by covid-19 epidemic
France85 participantsStarted 2017-12-23
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* No consent.
* Hypersensibility to Oseltamivir
* Negative PCR on nasopharyngeal swab
* Symptoms for more than 96 hours.
* Moribund patients at inclusion.
* Pregnant/nursing woman.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of alive patients without detection of influenza A virus by RT-PCR in nasopharyngeal swabs,
Timeframe: 7 days after the beginning of the treatment.