Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST)
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| ClinicalTrials.gov Identifier: NCT00061633 |
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Recruitment Status :
Completed
First Posted : June 2, 2003
Results First Posted : January 11, 2010
Last Update Posted : February 2, 2010
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Sponsor:
Theravance Biopharma Antibiotics, Inc.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
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Brief Summary:
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections | Drug: Telavancin Drug: Vancomycin or antistaphylococcal penicillin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 169 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | June 2003 |
| Actual Primary Completion Date : | January 2004 |
| Actual Study Completion Date : | January 2004 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Telavancin |
Drug: Telavancin
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Other Names:
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Active Comparator: Standard of care for cSSSI
cSSSI - complicated skin and skin structure infections
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Drug: Vancomycin or antistaphylococcal penicillin
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 Measures :
- 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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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:
- 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 infections
- Patients must be expected to require at least 4 days of intravenous 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 medication 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061633
Locations
| United States, California | |
| eStudy Site, 3450 Bonita Road, Ste 201 | |
| Chula Vista, California, United States, 91910 | |
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Investigators
| Principal Investigator: | G. Ralph Corey, MD | Duke University |
| 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 |
| First Posted: | June 2, 2003 Key Record Dates |
| Results First Posted: | January 11, 2010 |
| Last Update Posted: | February 2, 2010 |
| Last Verified: | January 2010 |
Additional relevant MeSH terms:
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Infection Communicable Diseases Wound Infection Cellulitis Gram-Positive Bacterial Infections Skin Diseases, Infectious Suppuration Connective Tissue Diseases |
Inflammation Pathologic Processes Bacterial Infections Vancomycin Penicillins Telavancin Anti-Bacterial Agents Anti-Infective Agents |