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Skin InfectionPhase 2NCT02052388

Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

A Phase 2 study testing Daptomycin and Brilacidin in people with Skin Infection and Bacterial Infection, run by Cellceutix Corporation at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Skin Infection, Bacterial Infection
What is being tested?
Daptomycin and Brilacidin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
4 sitesUnited States
Study dates
Feb 2014to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Greater than 10% bands or other immature neutrophils (total), irrespective of WBC count
  • Elevated C-reactive protein (CRP) (> 40 mg/L), if tested
  • 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:
  • Clinical evidence of treatment failure following at least 48 hours of prior systemic antimicrobial therapy; or
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • eStudy Site

    Chula Vista, California, 91911

  • eStudy Site

    La Mesa, California, 91942

  • eStudy Site

    Las Vegas, Nevada, 89109

  • eStudy Site

    Oceanside, California, 92056

Other trials in United States

About this study

Official title: 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)

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.

Read the 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.

Being tested
Daptomycin, Brilacidin
Keywords
Skin Infection, Staph aureus, MRSA, MSSA, Cellulitis/Erysipelas, Wound Infection, Abscess
Medical subject headings
Cellulitis, Bacterial Infections, Staphylococcal Infections, Erysipelas, Wound Infection, Abscess

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaptomycinDrug

    Also called Cubicin

    Active Comparator

  • BrilacidinDrug

    Also called PMX63

    Experimental Drug

Study groups in NCT02052388
Study groupRoleWhat they receive
Low Single Dose BrilacidinExperimental0.6mg/kg Brilacidin IV (single dose)
Receives: Drug: Brilacidin
High Single Dose BrilacidinExperimental0.8mg/kg Brilacidin IV (single dose)
Receives: Drug: Brilacidin
3-Day Regimen BrilacidinExperimental0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 \& 3
Receives: Drug: Brilacidin
Standard dosing regimen DaptomycinActive comparator4mg/kg Daptomycin IV daily for 7 Days
Receives: Drug: Daptomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48-72 hours after first dose of study drug

Secondary outcomes (2)

  1. Clinical Response

    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.

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

  2. Microbiological response

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052388
Sponsor's protocol ID
CTIX-BRI-204
Status last verified
Sep 2018
First submitted
30 Jan 2014
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daptomycin and Brilacidin in people with Skin Infection and Bacterial Infection, run by Cellceutix Corporation at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early clinical response (time frame: 48-72 hours after first dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02052388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.

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