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NCT04636554 Clinical Trial

Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia

Covid19 Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04636554
Other study ID # APT.APS.001
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date December 2021
Source Adaptive Phage Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Adaptive Phage Therapeutics, Inc.
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