Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636554
Expanded Access Status : Available
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Adaptive Phage Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Bacteriophage treatment in Covid-19 patients being treated with Anti-Microbials for Pneumonia or Bacteremia/Septicemia.

Condition or disease Intervention/treatment
Covid19 Bacteremia Septicemia Acinetobacter Baumannii Infection Pseudomonas Aeruginosa Infection Staph Aureus Infection 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 Design
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Sepsis

Interventions
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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.
Eligibility Criteria
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636554


Contacts
Layout table for location contacts
Contact: Robert J Hopkins, MD, MPH&TM, FACP, FIDSA 240-367-4006 rhopkins@aphage.com
Contact: Stephanie Holland 202-391-8058 sholland@aphage.com

Sponsors and Collaborators
Adaptive Phage Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Adaptive Phage Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04636554    
Other Study ID Numbers: APT.APS.001
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Keywords provided by Adaptive Phage Therapeutics, Inc.:
Covid19
Bacteriophage
Phage
Bacteremia
Septicemia
Acinetobacter
 baumannii
Pseudomonas
Aeruginosa
Infection
Staph
Aureus
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Bacteremia
Pseudomonas Infections
Sepsis
Toxemia
Pneumonia
Lung Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Negative Bacterial Infections