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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01593761
First received: May 6, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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

Condition Intervention Phase
Skin Infection
Drug: CG400549
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • • To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549. [ Time Frame: [10~14days], [28days] ] [ Designated as safety issue: Yes ]
    Clinical cure and microbial eradication rates, in the clinically evaluable (CE) and microbiologically evaluable (ME) populations, respectively, at EOT and TOC.


Enrollment: 20
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593761

Locations
United States, California
eStudysite
La Mesa, California, United States, 91942
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Principal Investigator: Jeffrey S. Overcash, MD eStudysite
  More Information

No publications provided

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01593761     History of Changes
Other Study ID Numbers: CG400549-2-01
Study First Received: May 6, 2012
Last Updated: December 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CrystalGenomics, Inc.:
cABSSSI
MRSA

Additional relevant MeSH terms:
Skin Diseases, Infectious
Staphylococcal Infections
Infection
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014