Back to resultsPersonalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
Primary Purpose
Covid19, Bacteremia, Septicemia
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Phage Therapy
Sponsored by
About this trial
This is an expanded access trial for Covid19 focused on measuring Covid19, Bacteriophage, Phage, Bacteremia, Septicemia, Acinetobacter, baumannii, Pseudomonas, Aeruginosa, Infection, Staph, 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04636554
First Posted
November 9, 2020
Last Updated
December 6, 2021
Sponsor
Adaptive Phage Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04636554
Brief Title
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptive Phage Therapeutics, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Bacteremia, Septicemia, Acinetobacter Baumannii Infection, Pseudomonas Aeruginosa Infection, Staph Aureus Infection
Keywords
Covid19, Bacteriophage, Phage, Bacteremia, Septicemia, Acinetobacter, baumannii, Pseudomonas, Aeruginosa, Infection, Staph, Aureus
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Phage Therapy
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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.
12. IPD Sharing Statement
Learn more about this trial
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
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