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Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02052388
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Innovation Pharmaceuticals, Inc. ( Cellceutix Corporation )

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE February 3, 2014
Last Update Posted Date September 26, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • Clinical Response [ Time Frame: Day 7-8; Day 10-14; Day 21-28 ]
    For Days 7/8 and 10-14, a response of Clinical Success will be assigned if all signs and symptoms of infection present at baseline have improved and/or resolved and no additional antibiotics are considered necessary. Subjects who have a response of Clinical Success at Day 10-14 will be assessed for sustained efficacy at Day 21-28. A response of Sustained Clinical Success will be assigned if all signs and symptoms remain resolved and no additional antibiotics are considered necessary. If signs and symptoms of infection recurred at the original site of infection and require additional antibiotic therapy, a response of Relapse will be assigned.
  • Microbiological response [ Time Frame: 48-72 hours; Day 7-8; Day 10-14 ]
    Microbiological responses for those subjects who had a relevant skin pathogen isolated at baseline (MITT and ME populations)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2014)
Plasma drug levels [ Time Frame: Days 1 (peak), 2 (trough) and 3 (trough and peak) ]
Brilacidin levels will be determined at specified times to aid in pharmacokinetic-pharmacodynamic analyses. These data will aid in dose selection for later stage trials.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
Official Title  ICMJE A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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.
Detailed Description

This is a randomized, multi-center, double-blind study to evaluate the efficacy and safety of three regimens of brilacidin compared to an active control, daptomycin, in subjects with ABSSSI. Subjects must have infections that warrant intravenous therapy but may be treated as either inpatients or outpatients.

Eligible subjects will be randomized to one of 4 treatment groups in a 1:1:1:1 ratio. Subjects randomized to brilacidin will receive either a single intravenous infusion (0.6 mg/kg or 0.8 mg/kg) followed by six days of once daily placebo, or a three day regimen (0.6 mg/kg on Day 1 followed by 0.3 mg/kg on Days 2 and 3) followed by 4 days of once daily placebo. Subjects randomized to daptomycin will receive 7 days of treatment. Subjects will be assessed for both clinical and microbiologic efficacy 48-72 hours after the first dose of study drug. After an assessment at Day 7-8, subjects will be again be evaluated for efficacy at Day 10-14 and via a phone contact at Day 21-28.

Approximately 200 subjects randomized in a 1:1:1:1 ratio to receive one of the three brilacidin regimens or daptomycin will be evaluable. The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the Intent-to treat (ITT) population. Additional efficacy and safety analyses will be performed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Infection
  • Bacterial Infection
Intervention  ICMJE
  • Drug: Daptomycin
    Active Comparator
    Other Name: Cubicin
  • Drug: Brilacidin
    Experimental Drug
    Other Name: PMX63
Study Arms  ICMJE
  • Experimental: Low Single Dose Brilacidin
    0.6mg/kg Brilacidin IV (single dose)
    Intervention: Drug: Brilacidin
  • Experimental: High Single Dose Brilacidin
    0.8mg/kg Brilacidin IV (single dose)
    Intervention: Drug: Brilacidin
  • Experimental: 3-Day Regimen Brilacidin
    0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 & 3
    Intervention: Drug: Brilacidin
  • Active Comparator: Standard dosing regimen Daptomycin
    4mg/kg Daptomycin IV daily for 7 Days
    Intervention: Drug: Daptomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2014)
215
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of written informed consent
  • Be ≥ 18 and ≤ 85 years of age
  • Have one of the following types of ABSSSI:

    1. 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.
    2. 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
    3. 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:

    1. Purulent or seropurulent drainage or discharge
    2. Erythema
    3. Fluctuance
    4. Heat or localized warmth
    5. Pain or tenderness to palpation
  • Have one or more of the following systemic signs:

    1. Temperature (oral or tympanic) ≥ 38⁰ C/100.4 F, as measured by the subject/caregiver or investigator up to 24 hours prior to baseline
    2. WBC count > 10,000/mm3
    3. Greater than 10% bands or other immature neutrophils (total), irrespective of WBC count
    4. Elevated C-reactive protein (CRP) (> 40 mg/L), if tested
    5. Presence of lymphadenitis or lymphadenopathy proximal to the infected area
  • Must not have received more than a single dose of a short-acting systemic antibiotic for the current ABSSSI within 72 hours prior to randomization, unless either of the following situations apply:

    1. Clinical evidence of treatment failure following at least 48 hours of prior systemic antimicrobial therapy; or
    2. The subject recently completed a course of antibiotic treatment for an infection other than ABSSSI and that drug is not active against the bacterial pathogens that typically cause ABSSSI.

Exclusion Criteria:

  • 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:

    1. Presence of an uncomplicated skin or skin structure infection, such as folliculitis, furunculosis, or minor abscess likely to respond to incision and drainage alone
    2. Suspected or confirmed osteomyelitis
    3. Suspected or confirmed septic arthritis
    4. 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:

    1. 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;
    2. Hypothermia (core temperature <35.6°C or <96.1°F);
    3. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02052388
Other Study ID Numbers  ICMJE CTIX-BRI-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innovation Pharmaceuticals, Inc. ( Cellceutix Corporation )
Study Sponsor  ICMJE Cellceutix Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William O'Riordan, MD eStudy SIte
PRS Account Innovation Pharmaceuticals, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP