Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion (DAD)

October 21, 2018 updated by: Sonescence, Inc.

This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic solution and then dispersed using high-frequency external ultrasound. Using this system, a much higher concentration of antibiotic can be achieved than through traditional treatment methods.

Unlike traditional delivery methods, Direct Antibiotic Delivery does not rely on blood supply and is beneficial for subjects with Diabetes or subjects who have received radiation therapy and blood supply is limited.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

In this study, the DOSAGE of cefazolin that is delivered is a fraction of that which is already FDA approved for intramuscular (IM) administration. However, the CONCENTRATION in the target area is much higher than what can be achieved through intravenous (IV) administration, while still being far less than what is approved for IM administration.

Previous to this study, cefazolin was considered to be ineffective in treating Methicillin-resistant Staphylococcus aureus (MRSA) as it had only been tested at the concentrations that were attainable by traditional methods. Through our study and laboratory tests conducted at the Harford Hospital, Connecticut, we have confirmed that cefazolin can be effective against even the most resistant strains of MRSA if a high enough concentration is obtained.

Under this study, treatment is only available to subjects that have already undergone standard therapy, but were not able to resolve the infection.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sebastopol, California, United States, 95472
        • Sonoma West Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with pathologically confirmed presence of serious or immediately life-threatening soft tissue infection, cellulitis or open wound caused by bacteria for which cefazolin at this concentration is likely to have activity to inhibit the bacteria, for example, Staphylococcus species or Streptococcus species, Escherichia coli, Proteus mirabilis.
  • Wounds must demonstrate the presence of skin and skin structure infection, which may be demonstrated by one or more of the following: Culture results as aforementioned, swelling of the tissues, discoloration, open wounds, and/or drainage, which may or may not be associated with pain and/or tenderness.
  • Confirmed presence of soft tissue cellulitis caused by bacteria for which cefazolin is likely to have activity to inhibit the bacteria will be evidenced by microbiologic cultures taken no greater than ten (10) days prior to treatment.
  • Subject must have previously been treated by a qualified licensed physician using traditional surgical and/or medical treatments, which may include courses of IV antibiotics, but where Subject was unable to resolve their infection through traditional surgical and/or medical treatments for soft tissue cellulitis caused by bacteria for which cefazolin is likely to have activity to inhibit the bacteria at a maximum concentration of 1 gram per 100 ml saline, as demonstrated by the presence of induration, redness, open wounds, and/or soft tissue swelling.
  • Subject must be referred by his or her treating physician to the Wound Care Center of the investigational hospital.
  • The Wound Care Center of the investigational hospital has confirmed that standard therapies have failed to cure the subject's infection and the infection is still present.
  • Subjects are not on concomitant antibacterial drugs since these drugs have failed to treat the subject's infection.
  • Subject may be male or female and must be at least 18 years of age.
  • Subject must sign informed consent as approved by the Institutional Review Board (IRB).

Exclusion Criteria:

  • Subjects who have not received treatment by traditional surgical and/or medical therapies.
  • Subjects who are allergic to cefazolin.
  • Subjects who have a serious allergy to penicillin.
  • Subjects with infections that involve body cavities.
  • Subjects designated to be vulnerable, i.e., pregnant women, subjects under the age of 18, and subjects who need to have consent provided by a Legally Authorized Representative (LAR).
  • Subjects who are unable or unwilling to comply with the protocol.
  • Subjects who have a history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3.
  • Subjects who have any other life-threatening illness or organ system dysfunction, which, in the opinion of the investigator, would either compromise subject safety or interfere with the evaluation of the safety of the test drug.
  • Subjects who cannot understand English.
  • Subjects who have received a treatment under this study are not eligible for re-admittance for thirty (30) days from the date of their last treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonescence, Inc.

Investigators

  • Principal Investigator: Barry N Silberg, MD, Sonoma West Medical Center, Santa Rosa Memorial Hospital, Sutter Health
  • Study Director: James K Gude, MD, Sonoma West Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 21, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 75,736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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