Official Title
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
Brief Summary

Phage Treatment in Covid-19 Patients with Bacterial Co-Infections

Detailed Description

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.

No longer available
Intermediate-size Population
Treatment IND/Protocol
COVID19
Bacteremia
Septicemia
Acinetobacter Baumannii Infection
Pseudomonas Aeruginosa Infection
Staph Aureus Infection

Other: Phage Therapy

Personalized intravenous phage therapy in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Adaptive Phage Therapeutics, Inc.
NCT Number
Keywords
COVID19
Bacteriophage
Phage
Bacteremia
Septicemia
Acinetobacter
baumannii
Pseudomonas
Aeruginosa
Infection
Staph
Aureus
MeSH Terms
Infections
Communicable Diseases
COVID-19
Pneumonia
Bacteremia
Pseudomonas Infections
Sepsis
Toxemia