OBJECTIVE: This phase 1 trial set out to examine the safety of a bacteriophage-based preparation for difficult-to-treat wounds. METHOD: The intention-to-treat sample comprised 42 patients with chronic venous leg ulcers (VLUs); 39 patients completed the trial. The ulcers were treated for 12 weeks with either a saline control or bacteriophages targeted against Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli. Follow-up continued until week 24. RESULTS: No adverse events were attributed to the study product. No significant difference (p>0.05) was determined between the test and control groups for frequency of adverse events, rate of healing, or frequency of healing. CONCLUSION: This study found no safety concerns with the bacteriophage treatment. Efficacy of the preparation will need to be evaluated in a phase II efficacy study. DECLARATION OF INTEREST: One of the authors (AS) holds an equity interest in Intralytix. The other authors do not have any interest in commercial activities.
RCT Entities:
OBJECTIVE: This phase 1 trial set out to examine the safety of a bacteriophage-based preparation for difficult-to-treat wounds. METHOD: The intention-to-treat sample comprised 42 patients with chronic venous leg ulcers (VLUs); 39 patients completed the trial. The ulcers were treated for 12 weeks with either a saline control or bacteriophages targeted against Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli. Follow-up continued until week 24. RESULTS: No adverse events were attributed to the study product. No significant difference (p>0.05) was determined between the test and control groups for frequency of adverse events, rate of healing, or frequency of healing. CONCLUSION: This study found no safety concerns with the bacteriophage treatment. Efficacy of the preparation will need to be evaluated in a phase II efficacy study. DECLARATION OF INTEREST: One of the authors (AS) holds an equity interest in Intralytix. The other authors do not have any interest in commercial activities.
Authors: Bradley Anderson; Mohammed H Rashid; Chandi Carter; Gary Pasternack; Chythanya Rajanna; Tamara Revazishvili; Timothy Dean; Andre Senecal; Alexander Sulakvelidze Journal: Bacteriophage Date: 2011-03
Authors: James M Regeimbal; Anna C Jacobs; Brendan W Corey; Matthew S Henry; Mitchell G Thompson; Rebecca L Pavlicek; Javier Quinones; Ryan M Hannah; Meron Ghebremedhin; Nicole J Crane; Daniel V Zurawski; Nimfa C Teneza-Mora; Biswajit Biswas; Eric R Hall Journal: Antimicrob Agents Chemother Date: 2016-09-23 Impact factor: 5.191
Authors: Casey J Holmes; Jennifer K Plichta; Richard L Gamelli; Katherine A Radek Journal: Adv Wound Care (New Rochelle) Date: 2015-01-01 Impact factor: 4.730
Authors: Robert T Schooley; Biswajit Biswas; Jason J Gill; Adriana Hernandez-Morales; Jacob Lancaster; Lauren Lessor; Jeremy J Barr; Sharon L Reed; Forest Rohwer; Sean Benler; Anca M Segall; Randy Taplitz; Davey M Smith; Kim Kerr; Monika Kumaraswamy; Victor Nizet; Leo Lin; Melanie D McCauley; Steffanie A Strathdee; Constance A Benson; Robert K Pope; Brian M Leroux; Andrew C Picel; Alfred J Mateczun; Katherine E Cilwa; James M Regeimbal; Luis A Estrella; David M Wolfe; Matthew S Henry; Javier Quinones; Scott Salka; Kimberly A Bishop-Lilly; Ry Young; Theron Hamilton Journal: Antimicrob Agents Chemother Date: 2017-09-22 Impact factor: 5.191
Authors: Pilar García; Beatriz Martínez; José María Obeso; Rob Lavigne; Rudi Lurz; Ana Rodríguez Journal: Appl Environ Microbiol Date: 2009-10-16 Impact factor: 4.792