Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

NCT02052388 | Completed Phase 2 DMC

• 1 other identifier: CTIX-BRI-204
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine the safety and efficacy of three different dosing regimens of brilacidin compared to daptomycin for the treatment of serious skin infections. This study will aid in selecting the appropriate dose of brilacidin for later stage studies.

Conditions

Skin Infection; Bacterial Infection

Keywords

Skin Infection; Staph aureus; MRSA; MSSA; Cellulitis/Erysipelas; Wound Infection; Abscess

Outcome Measures

Primary Outcomes (1)

• Early clinical response

  The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by ≥20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered.

  48-72 hours after first dose of study drug

Secondary Outcomes (2)

• Clinical Response

  Day 7-8; Day 10-14; Day 21-28

• Microbiological response

  48-72 hours; Day 7-8; Day 10-14

Other Outcomes (1)

• Plasma drug levels

  Days 1 (peak), 2 (trough) and 3 (trough and peak)

Study Arms (4)

Low Single Dose Brilacidin

EXPERIMENTAL

0.6mg/kg Brilacidin IV (single dose)

Drug: Brilacidin

High Single Dose Brilacidin

EXPERIMENTAL

0.8mg/kg Brilacidin IV (single dose)

Drug: Brilacidin

3-Day Regimen Brilacidin

EXPERIMENTAL

0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 \& 3

Drug: Brilacidin

Standard dosing regimen Daptomycin

ACTIVE COMPARATOR

4mg/kg Daptomycin IV daily for 7 Days

Drug: Daptomycin

Interventions

Daptomycin DRUG

Active Comparator

Also known as: Cubicin

Standard dosing regimen Daptomycin

Brilacidin DRUG

Experimental Drug

Also known as: PMX63

3-Day Regimen Brilacidin; High Single Dose Brilacidin; Low Single Dose Brilacidin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Be ≥ 18 and ≤ 85 years of age
• Have one of the following types of ABSSSI:
• A post-traumatic or post-surgical wound infection, occurring within 30 days of the trauma or surgery, characterized by purulent or seropurulent drainage from the wound and surrounding erythema, edema and/or induration of a minimum surface area of 75 cm2.
• A major cutaneous abscess, characterized by a collection of pus within the dermis or deeper tissues, accompanied by erythema, edema, and/or induration of a minimum surface area of 75 cm2. Note: patients with major cutaneous abscess will be limited to 30% of total enrollment
• Cellulitis/erysipelas, characterized by spreading areas of erythema, edema, and/or induration of a minimum surface area of 75 cm2.
• Have two or more of the following signs:
• Purulent or seropurulent drainage or discharge
• Erythema
• Fluctuance
• Heat or localized warmth
• Pain or tenderness to palpation
• Have one or more of the following systemic signs:
• Temperature (oral or tympanic) ≥ 38⁰ C/100.4 F, as measured by the subject/caregiver or investigator up to 24 hours prior to baseline
• WBC count \> 10,000/mm3

You may not qualify if:

• Female subjects who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
• Skin or skin structure infection with any of the following characteristics:
• Presence of an uncomplicated skin or skin structure infection, such as folliculitis, furunculosis, or minor abscess likely to respond to incision and drainage alone
• Suspected or confirmed osteomyelitis
• Suspected or confirmed septic arthritis
• Suspected or confirmed infection caused exclusively by Gram-negative pathogens or by any anaerobes
• Known hypersensitivity to daptomycin
• Known creatinine clearance \<50 mL/min (based on the Cockcroft-Gault formula using ideal body weight)
• Immunosuppression, defined as chronic corticosteroid use (20 mg prednisone/day or equivalent), solid organ or bone marrow transplantation, current cytotoxic chemotherapy, neutropenia (absolute neutrophil count \< 500/mm3), or known HIV infection with CD4+ count \< 200/mm3
• Platelet count \<50 x 103/L
• Exhibits signs of sepsis:
• Shock or profound hypotension, defined as systolic blood pressure \<90 mm Hg or a decrease of \>40 mm Hg from baseline that is not responsive to fluid challenge;
• Hypothermia (core temperature \<35.6°C or \<96.1°F);
• Disseminated intravascular coagulation as evidenced by prothrombin time (PT) or activated partial thromboplastin time (aPTT) 2 times the upper limit of normal;
• Inability or unwillingness to adhere to the study-specified procedures and restrictions

Sponsors & Collaborators

• Cellceutix Corporation: lead

Study Sites (4)

eStudy Site

Chula Vista, California, 91911, United States

Location

eStudy Site

La Mesa, California, 91942, United States

Location

eStudy Site

Oceanside, California, 92056, United States

Location

eStudy Site

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Conditions

Cellulitis; Bacterial Infections; Staphylococcal Infections; Erysipelas; Wound Infection; Abscess

Interventions

Daptomycin; brilacidin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• William O'Riordan, MD

  eStudy SIte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)