Bacteriophage Therapy in Patients With Urinary Tract Infections

Adaptive Phage Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Urinary Tract Infection Bacterial

Treatments: Biological: Bacteriophage Therapy

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04287478

APT.UTI.001

Details and patient eligibility

About

This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

Full description

This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

General 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.
• English-speaking.

General Exclusion Criteria:

• Stage 4 or greater chronic kidney disease (CKD).
• Abnormal liver function tests >3×upper limit of normal (ULN).
• Other conditions which could confound study results.
• Body mass index of > 40 or weight less than 50 kg.
• Known allergy to phage products.
• Pregnant and/or breastfeeding.
• Immunocompromised.
• Need for antiviral medication.
• History of severe autonomic dysreflexia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 6 patient groups

Intravenous (IV)

Experimental group

Description:

Phage administered via the intravenous route.

Treatment:

Biological: Bacteriophage Therapy

Intravesical (IVS)

Experimental group

Description:

Phage administered via the intravesical route.

Treatment:

Biological: Bacteriophage Therapy

Subcohort A

Experimental group

Description:

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

Treatment:

Biological: Bacteriophage Therapy

Subcohort B

Experimental group

Description:

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

Treatment:

Biological: Bacteriophage Therapy

Subcohort C

Experimental group

Description:

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

Treatment:

Biological: Bacteriophage Therapy

Subcohort D

Experimental group

Description:

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

Treatment:

Biological: Bacteriophage Therapy