Phase 3
N=573
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Abscess · Wound Infection · Surgical Site Infection · Cellulitis
Bottom Line
View on ClinicalTrials.gov: NCT01339091 ↗Enrolled (actual)
573
Serious AEs
3.0%
Results posted
Dec 2013
Primary outcome: Primary: Early Clinical Efficacy — 240; 233; 48; 52 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dalbavancin (Drug); Vancomycin / Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Clinical Efficacy |
240; 233; 48; 52 | — |
| SECONDARY >= 20% Reduction in Lesion Area |
259; 259; 29; 26 | — |
| SECONDARY Clinical Status |
212; 220; 14; 9 | — |
| SECONDARY Clinical Status |
212; 220; 14; 9 | — |
Summary
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.
Eligibility Criteria
Inclusion Criteria
- Male or female patients 18 - 85 years of age.
- Signed and dated informed consent document.
- Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
- At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
- Requires a minimum of 3 days of IV therapy.
- Patient willing and able to comply with study procedures.
Exclusion Criteria
Patients presenting with any of the following:
- A contra-indication to any required study drug.
- Pregnant or nursing females.
- Sustained shock.
- Participation in another study of an investigational drug or device within 30 days.
- Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
- Infection due to a dalbavancin or vancomycin-resistant organism.
- Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
- Exclusively gram-negative bacterial or a fungal ABSSSI.
- Venous catheter infection.
- Infection of a diabetic foot ulcer or a decubitus ulcer.
- Device-related infections.
- Gram-negative bacteremia.
- Infected burns.
- Infected limb with critical ischemia.
- Superficial/simple skin and skin structure infections.
- Concomitant condition requiring non-study antibacterial therapy.
- ABSSSI requiring therapy for longer than 14 days.
- Adjunctive therapy with hyperbaric oxygen.
- More than 2 surgical interventions for ABSSSI anticipated.
- Chronic inflammatory condition precluding assessment of clinical response.
- Absolute neutrophil count 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
- Life expectancy less than 3 months.
- Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
- Prior participation in the study.
Data sourced from ClinicalTrials.gov (NCT01339091). 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.