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) (FAST)

This study has been completed.

Study NCT00061633 Information provided by Theravance

First Received on May 30, 2003. Last Updated on January 27, 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, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections
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: 05Jun03 to 20Jan04

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	Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
Standard of Care for cSSSI	Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.

Participant Flow: Overall Study

	Telavancin	Standard of Care for cSSSI
STARTED	84	85
COMPLETED	79	74
NOT COMPLETED	5	11
Adverse Event	1	2
Withdrawal by Subject	2	2
Lost to Follow-up	1	4
Unknown	1	1
Never received study treatment	0	2

Baseline Characteristics

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Reporting Groups

	Description
Telavancin	Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
Standard of Care for cSSSI	Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.

Baseline Measures

	Telavancin	Standard of Care for cSSSI	Total
Number of Participants [units: participants]	84	83	167
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	80	78	158
>=65 years	4	5	9
Age [units: years] Mean ± Standard Deviation	44.6 ± 13.9	44.3 ± 13.5	44.4 ± 13.7
Gender [units: participants]
Female	30	37	67
Male	54	46	100
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	15	10	25
Not Hispanic or Latino	68	72	140
Unknown or Not Reported	1	1	2
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	1	1
Asian	4	1	5
Native Hawaiian or Other Pacific Islander	6	5	11
Black or African American	21	20	41
White	38	41	79
More than one race	13	14	27
Unknown or Not Reported	2	1	3
Region of Enrollment [units: participants]
United States	59	58	117
South Africa	25	25	50
Diabetes Status [units: participants]
Diabetic	25	19	44
Non-Diabetic	59	64	123

Outcome Measures

1. Primary:

Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 7-14 days following end 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:	NCT00061633 History of Changes
Other Study ID Numbers:	I6424-202a
Study First Received:	May 30, 2003
Results First Received:	December 2, 2009
Last Updated:	January 27, 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