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Trial · Interventional

CompletedPhase 2Registry data

Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

Overview

Status
Completed
Phase
Phase 2
Enrollment
215 participants (actual)
Sponsor
Cellceutix Corporation · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Feb 2014
Primary completion
Oct 2014
Completion
Oct 2014
First posted
3 Feb 2014 (estimated)
Last update posted
26 Sept 2018
Conditions
Skin Infection · Bacterial Infection

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 2

    Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

    NCT02052388

    Feb 2014 to Oct 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DaptomycinDrug
  • BrilacidinDrug

Arms4

  • Experimental

    Low Single Dose Brilacidin

    0.6mg/kg Brilacidin IV (single dose)

  • Experimental

    High Single Dose Brilacidin

    0.8mg/kg Brilacidin IV (single dose)

  • Experimental

    3-Day Regimen Brilacidin

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

  • Active comparator

    Standard dosing regimen Daptomycin

    4mg/kg Daptomycin IV daily for 7 Days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Early clinical response

    Time frame · 48-72 hours after first dose of study drug

    Registry description

    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.

Secondary outcomes(2)
  1. Clinical Response

    Time frame · Day 7-8; Day 10-14; Day 21-28

    Registry description

    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.

  2. Microbiological response

    Time frame · 48-72 hours; Day 7-8; Day 10-14

    Registry description

    Microbiological responses for those subjects who had a relevant skin pathogen isolated at baseline (MITT and ME populations)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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