Clinical trial NCT01593761: Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Infection
Keywords: cABSSSI
MRSA
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Status of Subject's Clinical Responses
timeFrame: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)
Secondary outcomes:
measure: Status of Subject's Clinical Response
timeFrame: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
measure: Status of Subject's Microbial Eradication Response
timeFrame: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)
measure: Overall Summary of Adverse Events
timeFrame: From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)
measure: Mean Plasma Concentration-time Profile of CG400549
timeFrame: Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: eStudysite
state: California
Study officials:
affiliation: eStudysite
name: Jeffrey S. Overcash, MD
role: PRINCIPAL_INVESTIGATOR
References: