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

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

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

Study Overview

• Status: No longer available
• Conditions: Covid19; Bacteremia; Septicemia; Pseudomonas Aeruginosa Infection; Acinetobacter Baumannii Infection; Staph Aureus Infection
• Intervention / Treatment: Other: Phage Therapy

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 Type: Expanded Access
• Expanded Access Type: Intermediate-size Population; Treatment IND/Protocol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Adaptive Phage Therapeutics, Inc.

Study record dates

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Infection; Covid19; Bacteremia; Bacteriophage; Phage; Acinetobacter; Pseudomonas; Septicemia; baumannii; Aeruginosa; Staph; Aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; COVID-19; Sepsis; Toxemia; Infections; Communicable Diseases; Pneumonia; Bacteremia; Pseudomonas Infections
• Other Study ID Numbers: APT.APS.001