CompletedPhase 2

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

United States20 participantsStarted 2012-06

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Status of Subject's Clinical Responses

Timeframe: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)

Trial details

NCT IDNCT01593761

SponsorCrystalGenomics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

Results submitted2013-04-11

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