Phase 2
N=169
Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Infections, Gram-Positive Bacterial · Abscess · Burns · Cellulitis · Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00061633 ↗Enrolled (actual)
169
Serious AEs
7.2%
Results posted
Jan 2010
Primary outcome: Primary: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population — 66; 66; 6; 3 participants — p=0.5289
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Telavancin (Drug); Vancomycin or antistaphylococcal penicillin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Jan 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population |
66; 66; 6; 3; 0; 0 | 0.5289 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00061633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.