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Clinical Trial Summary

The central aim of this trial is to investigate the safety and tolerability of Phage Cocktail-SPK as an adjunct to standard therapy for the prevention and treatment of burns susceptible to infection/or infected by S. aureus, P. aeruginosa, or K. pneumoniae species. It is hypothesized that no adverse events, clinical abnormalities, or changes in laboratory tests results related to the application of Phage Cocktail SPK Spray will be observed.


Clinical Trial Description

This is a Phase I, randomized, open-label, active controlled study to evaluate the safety and tolerability of a Phage Cocktail-SPK therapy for second degree burn wounds in adult patients. The wound will be clinically selected on the basis that it is a second degree burn less than 10 percent of total body surface area, and that, according to medical assessment, should heal without surgical intervention. The study is intended to include one site outside of the United States of America, namely the Royal Brisbane and Women's Hospital, in Brisbane, Queensland, Australia. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04323475
Study type Interventional
Source Phagelux Inc.
Contact Nancy Tawil, PhD
Phone 18002430116
Email ntawil@phagelux.com
Status Not yet recruiting
Phase Phase 1
Start date January 2022
Completion date August 2023

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