Phase 2 N=20 Treatment

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

Skin Infection

Bottom Line

View on ClinicalTrials.gov: NCT01593761 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Status of Subject's Clinical Responses — 10; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CG400549 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CrystalGenomics, Inc.
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Status of Subject's Clinical Responses	10; 1	—
SECONDARY Status of Subject's Clinical Response	8; 1; 0; 9; 0; 0	—
SECONDARY Status of Subject's Microbial Eradication Response	—	—
SECONDARY Overall Summary of Adverse Events	13; 10; 0; 0; 7; 5	—
SECONDARY Mean Plasma Concentration-time Profile of CG400549	32.921; 426.921; 1,366.159; 1,618.997	—

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Prior systemic or topical antibacterial therapy
Severe sepsis or refractory shock

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01593761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.