Bacteriophage Therapy in Patients With Urinary Tract Infections

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Robert J Hopkins, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Adaptive Phage Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment that uses viruses to kill bacteria in patients with urinary tract infections. It focuses on people with infections caused by E. coli and K. pneumoniae, including those with recurring or complicated cases. The goal is to see if this treatment can safely and effectively clear the infection. Bacteriophage therapy has shown potential as an effective and safe treatment for urinary tract infections, but there is a lack of comprehensive studies.

Research Team

Robert J Hopkins, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

Inclusion Criteria

Males or females ≥18 years of age.

Female patients of childbearing potential.

Male patients must agree not to donate sperm up for one month.

Treatment Details

Interventions

• Bacteriophage Therapy (Virus Therapy)

Participant Groups

Group I: Subcohort D Experimental Treatment 1 Intervention

Selected phage for Klebsiella pneumoniae administered via selected route based on previous arms.

Group II: Subcohort C Experimental Treatment 1 Intervention

Selected phage for E. coli administered via selected route based on previous Arms.

Group III: Subcohort B Experimental Treatment 1 Intervention

Selected phage for Klebsiella pneumoniae administered via selected route based on previous Arms.

Group IV: Subcohort A Experimental Treatment 1 Intervention

Selected phage for E. coli administered via selected route based on previous Arms.

Group V: Intravesical (IVS) Experimental Treatment 1 Intervention

Phage administered via the intravesical route.

Group VI: Intravenous (IV) Experimental Treatment 1 Intervention

Phage administered via the intravenous route.

Who Is Running the Clinical Trial?

Adaptive Phage Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

130+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences