Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Phase 3

Completed

• Conditions: Cellulitis; Abscess; Surgical Site Infection; Wound Infection
• Interventions: Drug: Vancomycin/Linezolid; Drug: IV Dalbavancin

• Registration Number: NCT01431339
• Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc

Brief 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 proved gram-positive bacterial skin or skin structure infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-27
• Results First Submitted QC: 2013-12-27
• Last Update Submitted: 2013-12-27
• Results First Posted: 2014-02-12
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

1. Male or female patients 18 - 85 years of age.
2. Signed and dated informed consent document.
3. Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
4. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
5. Requires a minimum of 3 days of IV therapy.
6. Patient willing and able to comply with study procedures.

Exclusion Criteria

Patients presenting with any of the following:

1. A contra-indication to any required study drug.
2. Pregnant or nursing females.
3. Sustained shock.
4. Participation in another study of an investigational drug or device within 30 days.
5. 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.
6. Infection due to a dalbavancin or vancomycin-resistant organism.
7. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
8. Exclusively gram-negative bacterial or a fungal ABSSSI.
9. Venous catheter infection.
10. Infection of a diabetic foot ulcer or a decubitus ulcer.
11. Device-related infections.
12. Gram-negative bacteremia.
13. Infected burns.
14. Infected limb with critical ischemia.
15. Superficial/simple skin and skin structure infections.
16. Concomitant condition requiring non-study antibacterial therapy.
17. ABSSSI requiring therapy for longer than 14 days.
18. Adjunctive therapy with hyperbaric oxygen.
19. More than 2 surgical interventions for ABSSSI anticipated.
20. Chronic inflammatory condition precluding assessment of clinical response.
21. Absolute neutrophil count < 500 cells/mm3.
22. Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3.
23. Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
24. Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
25. Life expectancy less than 3 months.
26. Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
27. Prior participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin with possible switch to oral linezolid	Vancomycin/Linezolid	-
Dalbavancin	IV Dalbavancin	-

Primary Outcome Measures

Name	Time	Method
Early Clinical Efficacy	After 48-72 hours of therapy	Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature

Secondary Outcome Measures

Name	Time	Method
Clinical Status	Follow-Up Visit (day 28)	Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy
>= 20% Reduction in Lesion Area	48-72 hours after the initiation of study therapy	Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size

Trial Locations

Locations (5)

Durata Study Site; 🇺🇦 Zaporizhia, Ukraine

Durata Clinical Trial; 🇷🇴 Bucharest, Romania

Durata Study SIte; 🇺🇸 San Diego, California, United States

Durata Clinical Site; 🇺🇦 Kyiv, Ukraine

Durata Clinical SIte; 🇭🇺 Pecs, Hungary