Expanded Access Study of Phage Treatment in Covid-19 Patients on Anti-Microbials for Pneumonia or Bacteremia/Septicemia Due to A. Baumannii, P. Aeruginosa or S. Aureus
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
详细描述
The treatment approach will be to make phage therapy available to institutions who care for Covid-19 patients with bacterial co-infections due to A. baumannii, P. aeruginosa or S. aureus. Patient bacterial isolates will be tested to determine phage susceptibility prior to and during phage therapy.
The primary objectives are to determine the feasibility of developing, producing and providing a personalized intravenous phage for Covid-19 patients who have pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus and to evaluate the safety of intravenous phage in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.
研究设计
- 研究类型
- Expanded Access
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
- •Covid-19 patients with pneumonia or bacteremia/septicemia who have culture-confirmed bacterial co-infection with A. baumannii, P. aeruginosa or S. aureus.
- •Patient provided informed and signed consent.
排除标准
- •Patient eligible for another APT sponsored trial.
- •Patient participating in another clinical trial at the same time or patients < 4 weeks from participating in an alternative investigational protocol/study
- •Patient with known allergy to infusion of phage products
- •Patients with a history of Meningitis or encephalitis at time of study entry, Primary immune deficiency disease or tuberculosis or Stroke, transient ischemic attack (TIA), or untreated deep vein thrombosis.