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
| Registry | NCT04636554 |
|---|---|
| Status | No longer available |
| Study type | Expanded access |
| Sponsor | Adaptive Phage Therapeutics, Inc. (Industry) |
| Conditions | Covid19, Bacteremia, Septicemia, Acinetobacter Baumannii Infection, Pseudomonas Aeruginosa Infection, Staph Aureus Infection |
| Interventions | Phage Therapy (Other) |
| Dates | first posted 2020-11-19, last updated 2021-12-21 |
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All trials for Covid19 All trials for Bacteremia All trials of Phage Therapy
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
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.
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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.