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

Primary Purpose

Infections, Gram-positive Bacterial

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telavancin
vancomycin or antistaphylococcal penicillin
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Gram-positive Bacterial focused on measuring Abscess, Burns, Cellulitis, Ulcer, Wound infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism major abscess requiring surgical incision and drainage infected burn (see exclusion criteria for important qualifications) deep/extensive cellulitis infected ulcer (see exclusion criteria for important qualifications) wound infection Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment Exclusion Criteria: Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days) Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

Sites / Locations

  • Paradise Valley Hospital, 2400 E. 4th Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telavancin

Standard of care for cSSSI

Arm Description

cSSSI - comlicated skin and skin structure infections

Outcomes

Primary Outcome Measures

Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit Indeterminate: Inability to determine outcome.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2004
Last Updated
January 14, 2019
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00077675
Brief Title
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Acronym
FAST2
Official Title
A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Gram-positive Bacterial
Keywords
Abscess, Burns, Cellulitis, Ulcer, Wound infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telavancin
Arm Type
Experimental
Arm Title
Standard of care for cSSSI
Arm Type
Active Comparator
Arm Description
cSSSI - comlicated skin and skin structure infections
Intervention Type
Drug
Intervention Name(s)
Telavancin
Other Intervention Name(s)
TD-6424, VIBATIV
Intervention Description
Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
Intervention Type
Drug
Intervention Name(s)
vancomycin or antistaphylococcal penicillin
Intervention Description
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
Primary Outcome Measure Information:
Title
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Description
Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit Indeterminate: Inability to determine outcome.
Time Frame
7 to 14 days following completion of antibiotic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism major abscess requiring surgical incision and drainage infected burn (see exclusion criteria for important qualifications) deep/extensive cellulitis infected ulcer (see exclusion criteria for important qualifications) wound infection Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment Exclusion Criteria: Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days) Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Ralph Corey, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paradise Valley Hospital, 2400 E. 4th Street
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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