Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) - Study Results

Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)

This study has been completed.

Study NCT00077675 Information provided by Theravance

First Received on February 10, 2004. Last Updated on May 13, 2010 History of Changes

Results First Received: December 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Infections, Gram-Positive Bacterial
Interventions:	Drug: Telavancin Drug: vancomycin or antistaphylococcal penicillin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment Period: 20Feb2004 to 09SEP2004

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Telavancin	Telavancin 10 mg/kg every 24 hours intravenously
Standard of Care for cSSSI	Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]

Participant Flow: Overall Study

	Telavancin	Standard of Care for cSSSI
STARTED	103	98
COMPLETED	92	89
NOT COMPLETED	11	9
Adverse Event	1	2
Lost to Follow-up	6	3
Withdrawal by Subject	1	0
Unknown	0	1
Never received study treatment	3	3

Baseline Characteristics

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Reporting Groups

	Description
Telavancin	Telavancin 10 mg/kg every 24 hours intravenously
Standard of Care for cSSSI	Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]

Baseline Measures

	Telavancin	Standard of Care for cSSSI	Total
Number of Participants [units: participants]	100	95	195
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	92	91	183
>=65 years	8	4	12
Age [units: years] Mean ± Standard Deviation	44.7 ± 13.7	42.3 ± 10.8	43.6 ± 12.4
Gender [units: participants]
Female	45	33	78
Male	55	62	117
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	14	17	31
Not Hispanic or Latino	86	78	164
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	1	0	1
Asian	2	2	4
Native Hawaiian or Other Pacific Islander	3	1	4
Black or African American	29	30	59
White	41	43	84
More than one race	24	19	43
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
United States	58	54	112
South Africa	42	41	83
Diabetes Status [units: participants]
Diabetic	18	14	32
Not Diabetic	82	81	163

Outcome Measures

1. Primary:

Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 7 to 14 days following completion of antibiotic treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance, Inc
phone: 650-808-6132
e-mail: sbarriere@theravance.com

No publications provided

Responsible Party:	Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT00077675 History of Changes
Other Study ID Numbers:	I6424-202b
Study First Received:	February 10, 2004
Results First Received:	December 2, 2009
Last Updated:	May 13, 2010
Health Authority:	South Africa: Department of Health; South Africa: Human Research Ethics Committee; South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council; United States: Food and Drug Administration