Phase 2
N=201
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
Bottom Line
View on ClinicalTrials.gov: NCT00077675 ↗Enrolled (actual)
201
Serious AEs
5.1%
Results posted
Jan 2010
Primary outcome: Primary: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population — 74; 72; 3; 5 participants — p=0.5318
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
- Sep 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population |
74; 72; 3; 5 | 0.5318 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00077675). 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.