Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus (CG400549)

Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)

Primary Objective:

To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.

Secondary Objective(s):

• To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA
• To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.
• To assess the safety of multiple doses of CG400459

Study Overview

• Status: Completed
• Conditions: Skin Infection
• Intervention / Treatment: Drug: CG400549

Detailed Description

This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.

Subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • eStudySite

Participation Criteria

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:

1. Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.
2. Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation

Exclusion Criteria:

1. Prior systemic or topical antibacterial therapy
2. Severe sepsis or refractory shock

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm for CG400549; All the patients will be administered with CG400549.	Drug: CG400549; 960mg QD at fed state approx 1 hour after meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Status of Subject's Clinical Responses	Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (< 37.7 °C)	Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Status of Subject's Clinical Response	Clinical cure was defined as absence of fever (< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure.; Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms.; clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs	End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
Status of Subject's Microbial Eradication Response	Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms.; Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure.; Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.	End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
Overall Summary of Adverse Events	Treatment-Emergent Adverse Event (TEAE) are those that; Emerging during treatment, having been absent pre-treatment or; Reemerge during treatment, having been present at baseline but stopped prior to treatment or; Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.	From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)
Mean Plasma Concentration-time Profile of CG400549	The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.	Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour

Collaborators and Investigators

• Sponsor: CrystalGenomics, Inc.
• Investigators: Principal Investigator: Jeffrey S. Overcash, MD, eStudySite

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 6, 2012
• First Submitted That Met QC Criteria: May 6, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: MRSA; cABSSSI
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Connective Tissue Diseases; Suppuration; Infections; Cellulitis; Skin Diseases, Infectious
• Other Study ID Numbers: CG400549-2-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED