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

• Conditions: Covid19; Bacteremia; Septicemia; Acinetobacter Baumannii Infection; Pseudomonas Aeruginosa Infection; Staph Aureus Infection

• Registration Number: NCT04636554
• Lead Sponsor: Adaptive Phage Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-15
• Study First Posted: 2020-11-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified