Status:
TERMINATED
Bacteriophage Therapy in Patients With Urinary Tract Infections
Lead Sponsor:
Adaptive Phage Therapeutics, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Urinary Tract Infection Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.
Detailed 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 ...
Eligibility Criteria
Inclusion
- General
- 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
- 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.
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04287478
Start Date
December 9 2020
End Date
February 28 2023
Last Update
March 3 2023
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Universal Axon Clinical Research
Doral, Florida, United States, 33166
2
AdMed Research
Miami, Florida, United States, 33176
3
AMPM Research Clinic
Miami Gardens, Florida, United States, 33169
4
Innovation Medical Research Center, Inc
Palmetto Bay, Florida, United States, 33157