Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05269121
Other study ID # APT.PJI.002
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2022
Est. completion date November 2024

Study information

Verified date February 2024
Source Adaptive Phage Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.


Description:

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae. This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2024
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males or females =18 years of age. - Stopped or not received SAT for 2 weeks - Female patients of childbearing potential who agree to use contraception. - First time chronic prosthetic joint infection - Confirmed phage match - No anticipated need for long-term antibiotics Exclusion Criteria: - Soft tissue defect requiring reconstruction. - Hardware misalignment - Additional orthopedic hardware in connection with the infected prosthesis. - Active infection - Unable to tolerate SAT - Septic shock or hemodynamic instability. - Chronic kidney disease - Liver disease - Decompensated heart failure. - Positive drug screen - Receiving chemotherapy - Immunocompromised - Antiviral treatment within 2 weeks prior to DAIR - Currently participating in another clinical trial - Known phage allergy - Pregnant/ breastfeeding - Lack of capacity to consent

Study Design


Intervention

Biological:
Phage Therapy
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Adaptive Phage Therapeutics, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection Incidence of reactions to study treatment and discontinuation due to adverse events Day 1 through Week 24
Primary Treatment success No recurrence or evidence of infection with the original pathogen at the same joint 13 months after DAIR
Secondary No recurrence or evidence of infection for any reason Infection due to the original or different pathogen at the index site 3, 6, 13, or 24 months after DAIR
See also
  Status Clinical Trial Phase
Completed NCT03726216 - Xydalba Utilization Registry in France
Completed NCT03605498 - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Recruiting NCT02074865 - Children's Antibiotic Resistant Infections in Low Income Countries N/A
Completed NCT01689207 - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Phase 1
Completed NCT01932034 - Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software N/A
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Not yet recruiting NCT01159470 - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children N/A
Completed NCT00983255 - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) Phase 1
Completed NCT00799591 - French Study In ICU Patients Treated With Tigecycline N/A
Completed NCT00678106 - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Phase 1
Completed NCT01074775 - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection N/A
Completed NCT00478855 - Tazocin Intervention Study Phase 4
Terminated NCT00431028 - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery Phase 1/Phase 2
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Recruiting NCT05684705 - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Phase 1
Recruiting NCT03858387 - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation NCT04764058 - Efficacy and Safety of Colistin Based Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2
Completed NCT03332732 - VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers Phase 1