Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus (CG400549)
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|ClinicalTrials.gov Identifier: NCT01593761|
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : December 31, 2012
To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Skin Infection||Drug: CG400549||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||June 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||October 2012|
Experimental: Single Arm for CG400549
All the patients will be administered with CG400549.
960mg QD at fed state approx 1 hour after meal
- To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. [ Time Frame: at 48 to 72 hours after enrollment ]The primary efficacy endpoint will be cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size of redness, edema, and/or induration at 48 to 72 hours after enrollment and absence of fever in the microbiological modified intent-to-treat population.
- • To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549. [ Time Frame: [10~14days], [28days] ]Clinical cure and microbial eradication rates, in the clinically evaluable (CE) and microbiologically evaluable (ME) populations, respectively, at EOT and TOC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593761
|United States, California|
|La Mesa, California, United States, 91942|
|Principal Investigator:||Jeffrey S. Overcash, MD||eStudysite|