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

NCT ID: NCT04636554

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19 Bacteremia Septicemia Acinetobacter Baumannii Infection Pseudomonas Aeruginosa Infection Staph Aureus Infection

Keywords

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Covid19 Bacteriophage Phage Bacteremia Septicemia Acinetobacter baumannii Pseudomonas Aeruginosa Infection Staph Aureus

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adaptive Phage Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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APT.APS.001

Identifier Type: -

Identifier Source: org_study_id