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

NCT01593761 | Completed Phase 2 Results

• 1 other identifier: CG400549-2-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Infection

Keywords

cABSSSI; MRSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Status of Subject's Clinical Response

  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

  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

  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

  Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour

Study Arms (1)

Single Arm for CG400549

EXPERIMENTAL

All the patients will be administered with CG400549.

Drug: CG400549

Interventions

CG400549 DRUG

960mg QD at fed state approx 1 hour after meal

Single Arm for CG400549

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior systemic or topical antibacterial therapy
• Severe sepsis or refractory shock

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

eStudysite

La Mesa, California, 91942, United States

Location

MeSH Terms

Conditions

Cellulitis

Interventions

CG 400549

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Seonggu Ro, Ph.D, Chief Technology Officer
• Organization: CrystalGenomics, Inc.

sgro@cgxinc.com

82 31 628 2783

Study Officials

• Jeffrey S. Overcash, MD

  eStudysite

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 8, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 10, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-08

Locations

US (1)