Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | June 2012 |
| End Date: | October 2012 |
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
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
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.
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.
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
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