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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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)

Conditions
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Skin Infection

Intervention / Treatment
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* Drug: CG400549


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA. 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: Prior systemic or topical antibacterial therapy Severe sepsis or refractory shock

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cABSSSI, MRSA