NCT03212716终止2 期
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.
University Hospital, Lille19 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2017年12月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 试验地点
- 19
- 主要终点
- Percentage of alive patients without detection of influenza A virus by RT-PCR in nasopharyngeal swabs,
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
diltiazem
Experimental
oseltamivir + diltiazem
干预措施: Oseltamivir (Drug)
diltiazem
Experimental
oseltamivir + diltiazem
干预措施: Diltiazem (Drug)
oseltamivir + placebo
Placebo Comparator
oseltamivir + placebo of diltiazem
干预措施: Oseltamivir (Drug)
oseltamivir + placebo
Placebo Comparator
oseltamivir + placebo of diltiazem
干预措施: Placebos (Drug)
结局指标
主要结局
Percentage of alive patients without detection of influenza A virus by RT-PCR in nasopharyngeal swabs,
时间窗: 7 days after the beginning of the treatment.
次要结局
- Delay needed for the negativation of influenza A detection by RT-PCR(up to 10days)
- Overall mortality(At 28 days)
- Length of mechanical ventilation(an average of 10 days)
- Change in Oxygenation (PaO2/FiO2 Ratio)(once day for 10 days and at 28 days)
- Length of hospitalization(an average of 10 days in ICU and of 16 days in hospital)
- Length of extracorporeal membrane oxygenation (ECMO) if implemented.(an average of 10 days)
- Transcriptomic signature determined by the DNA microarray technology and analysed by bioinformatic tools(Four time points : at inclusion, the first day after inclusion, the fourth day after inclusion, and the seventh day after inclusion)
研究者
研究点 (19)
Loading locations...
相似试验
撤回
1 期
Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic CancerLymphomaLeukemiaNCT00003435Duke University
已完成
3 期
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 InfectionInfection, Human Immunodeficiency Virus IHIV InfectionNCT00440947ViiV Healthcare515
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced AdultsChronic Hepatitis C InfectionNCT01854528AbbVie148
终止
2 期
Mouth Rinses for Inactivation of COVID-19Covid19SARS-CoV-2 InfectionCoronavirus InfectionNCT04584684University of North Carolina, Chapel Hill128
已完成
2 期
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-InfectionHepatitis C Infection With HIV Co-InfectionNCT02457611Gilead Sciences26