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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

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

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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.

Conditions

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Skin Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm for CG400549

All the patients will be administered with CG400549.

Group Type EXPERIMENTAL

CG400549

Intervention Type DRUG

960mg QD at fed state approx 1 hour after meal

Interventions

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CG400549

960mg QD at fed state approx 1 hour after meal

Intervention Type DRUG

Eligibility Criteria

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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