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Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients

NCT04323475 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-12-22

No results posted yet for this study

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.

Conditions

  • Wound Infection

Interventions

BIOLOGICAL

Bacteriophage cocktail spray

Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages at a concentration of 1.4 x 10\^8 PFU/mL for an effective dosage of 2.5 x10\^5 PFU/cm\^2 of burned area. The study intervention will be applied in conjunction with standard of care.

DRUG

Xeroform

Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)

Sponsors & Collaborators

  • Precisio Biotix Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy Tawil, PhD · Precisio Biotix Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-01-31
Completion
2023-08-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323475 on ClinicalTrials.gov