Bacteriophage Therapy in Patients With Urinary Tract Infections

  • STATUS
    Recruiting
  • End date
    Sep 12, 2023
  • participants needed
    156
  • sponsor
    Adaptive Phage Therapeutics, Inc.
Updated on 12 December 2021

Summary

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

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.

Details
Condition Urinary Tract Infection Bacterial
Treatment Bacteriophage Therapy, Bacteriophage Therapy
Clinical Study IdentifierNCT04287478
SponsorAdaptive Phage Therapeutics, Inc.
Last Modified on12 December 2021

Eligibility

Yes No Not Sure

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

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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