Phase 2a Study of CG400549 for the Treatment of cABSSSI C... | NCT01593761

Phase 2a Study of CG400549 for the Treatment of cABSSSI C... | NCT01593761 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Single Arm for CG400549	Experimental	All the patients will be administered with CG400549.	Drug: CG400549

Name	Type	Description	Arm Group Labels	Other Names
CG400549	Drug	960mg QD at fed state approx 1 hour after meal	Single Arm for CG400549

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Status of Subject's Clinical Response	Clinical cure was defined as absence of fever (< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure. Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms. clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs

Contacts/Locations Module

Name	Affiliation	Role
Jeffrey S. Overcash, MD	eStudysite	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
eStudysite		La Mesa	California	91942	United States

ID	Title	Description
FG000	Subjects Received CG400549, MITT	All enrolled subjects who received any amount of study drug and was equivalent to the safety population.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00020 subjects
COMPLETED		FG00012 subjects
NOT COMPLETED		FG0008 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0001 subjects
culture negative for MRSA at baseline		FG0005 subjects
positive for hepatitis C virus		FG000

Baseline Characteristics Module

ID	Title	Description
BG000	Subjects Received CG400549, MITT	All enrolled subjects who received any amount of study drug and was equivalent to the safety population.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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)

Among 20 participated subjects, 11 subjects had confirmed MRSA and qualified for the mMITT population

Posted

Number

participants

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

ID	Title	Description
OG000	Subjects Proven MRSA, mMITT	The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subjects Proven MRSA, mMITT	The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
infection	Infections and infestations	MedDRA version 15.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Seonggu Ro, Ph.D, Chief Technology Officer	CrystalGenomics, Inc.	82 31 628 2783		sgro@cgxinc.com

Condition Browse Module

ID	Term
D002481	Cellulitis

ID	Term
D012874	Skin Diseases, Infectious
D007239	Infections
D013492	Suppuration
D003240	Connective Tissue Diseases

ID	Term
C523750	CG 400549

Units	Counts
Participants	OG00011

Secondary

Status of Subject's Clinical Response

Clinical cure was defined as absence of fever (< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure.
Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms.
clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs

Among 11 mMITT population who had proven MRSA , 2 subjects had major protocol violations, yielding 9 subjects for CE population

Posted

Number

participants

End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)

ID	Title	Description
OG000	Subjects Proven MRSA, CE	Primary population for assessment of clinical cure and was defined separately for the EOT and TOC visits. The mMITT subjects who did not have major protocol violations and received at least 80% of the planned dose of CG400549 were candidates for the CE population. CE subjects at EOT who met the above criteria and had a clinical lesion assessment at the EOT visit. CE subjects at TOC who met the above criteria and had a clinical lesion assessment at the TOC visit.

Units	Counts
Participants	OG0009

Title

Denominators

Categories

Clinical Cure at EOT

Title	Measurements
	OG0008(51.8 to 99.7)

Clinical Improvement at EOT

Title	Measurements
	OG0001(66.4 to 100)

Clinical Failure at EOT

Secondary

Status of Subject's Microbial Eradication Response

Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms.
Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure.
Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.

The ME group was not analyzed because the appropriate post-treatment skin culture data were not accessible due to the improvement of infected lesion.

Posted

End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)

ID	Title	Description
OG000	Subjects Proven MRSA, ME	The primary population for assessment of microbial eradiation and was defined separately for the EOT and TOC visits. The mMITT subjects who did not have major protocol violations and received at least 80% of the planned dose of CG400549 were candidates for the ME population. ME subjects at EOT who met the above criteria and had an interpretable culture for microbial response at EOT. ME subjects at TOC who met the above criteria and had an interpretable culture for microbial response at TOC.

Units	Counts
Participants	OG0000

Secondary

Overall Summary of Adverse Events

Treatment-Emergent Adverse Event (TEAE) are those that

Emerging during treatment, having been absent pre-treatment or
Reemerge during treatment, having been present at baseline but stopped prior to treatment or
Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.

Posted

Number

participants

From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)

ID	Title	Description
OG000	Subjects Received CG400549, MITT	All enrolled subjects who receive any amount of study drug and was equivalent to the safety population.
OG001	Subjects Proven MRSA, mMITT	The mMITT population was the primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA

Units	Counts
Participants	OG00020 OG00111

Title

Denominators