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

Surgical Site Infection Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regiment (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339091
• Other study ID #: DUR001-301
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2011
• Last updated: December 26, 2013
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: Durata Therapeutics Inc., an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Cellulitis
• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
• Vancomycin / Linezolid
IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.

Locations

Country	Name	City	State
Canada	Durata Study Site	Trois-Rivieres	Quebec
Canada	Durata Study Site	Winnipeg	Manitoba
Croatia	Durata Study Site	Dubrovnik
Croatia	Durata Clinical Site	Slavonski Brod
Croatia	Durata Study Site	Zagreb
Croatia	Durata Study Site	Zagreb
Georgia	Durata Clinical Site	Tbilisi
Germany	Durata Study Site	Bochum
Germany	Durata Study Site	Munster
Poland	Durata Study Site	Krakow
Poland	Durata Study Site	Legionowo
Poland	Durata Study Site	Warszawa
Poland	Durata Study Site	Wroclaw
Russian Federation	Durata Study Site	Ekaterinburg
Russian Federation	Durata Study Site	Kharkiv	Ukraine
Russian Federation	Durata Study Site	Kyiv city	Ukraine
Russian Federation	Durata Clinical Site	Moscow
Russian Federation	Durata Study Site	Moscow
Russian Federation	Durata Study Site	Moscow
Russian Federation	Durata Study Site	Perm
Russian Federation	Durata Study Site	Saratov
Russian Federation	Durata Study Site	Smolensk
Russian Federation	Durata Clinical Site	St. Petersburg
Russian Federation	Durata Study Site	St. Petersburg
Russian Federation	Durata Study Site	St. Petersburg
Russian Federation	Durata Study Site	St. Petersburg
Russian Federation	Durata Study Site	St. Petersburg
Russian Federation	Durata Study Site	Tomsk
Ukraine	Durata Study Site	Cherkasy
Ukraine	Durata Study Site	Ivano-Frankivsk
Ukraine	Durata Study Site	Kharkiv
Ukraine	Durata Study Site	Kyiv
Ukraine	Durata Study Site	Kyiv
Ukraine	Durata Study Site	Uzhgorod
Ukraine	Durata Study Site	Zaporizhzhya
Ukraine	Durata Study Site	Zhytomyr
United States	Durata Study Site	Anaheim	California
United States	Durata Study Site	Azusa	California
United States	Durata Study Site	Baton Rouge	Louisiana
United States	Durata Study Site	Bellflower	California
United States	Durata Study Site	Bronx	New York
United States	Durata Study Site	Buena Park	California
United States	Durata Study Site	Buffalo	New York
United States	Durata Study Site	Carmel	California
United States	Durata Study Site	Chula Vista	California
United States	Durata Study Site	Columbus	Georgia
United States	Durata Study Site	Columbus	Ohio
United States	Durata Study Site	Covina	California
United States	Durata Study Site	Detroit	Michigan
United States	Durata Study Site	Fountain Valley	California
United States	Durata Study Site	Houston	Texas
United States	Durata Study Site	Houston	Texas
United States	Durata Study Site	Idaho Falls	Idaho
United States	Durata Study Site	La Mesa	California
United States	Durata Study Site	Lafayette	Louisiana
United States	Durata Study Site	Lake Success	New York
United States	Durata Study Site	Las Vegas	Nevada
United States	Durata Study Site	Lima	Ohio
United States	Durata Study Site	Long Beach	California
United States	Durata Study Site	Los Alamitos	California
United States	Durata Study Site	Los Angeles	California
United States	Durata Study Site	Madison	Wisconsin
United States	Durata Study Site	Miami	Florida
United States	Durata Study Site	Miami	Florida
United States	Durata Study Site	Middleton	Wisconsin
United States	Durata Study Site	Minneapolis	Minnesota
United States	Durata Study Site	Moline	Illinois
United States	Durata Study Site	New Hyde Park	New York
United States	Durata Clinical Site	New Orleans	Louisiana
United States	Durata Study Site	Oceanside	California
United States	Durata Study Site	Opelousas	Louisiana
United States	Durata Study Site	Orlando	Florida
United States	Durata Study Site	Palm Desert	California
United States	Durata Study Site	Pasadena	California
United States	Durata Study Site	Pittsburgh	Pennsylvania
United States	Durata Study Site	Pocatello	Idaho
United States	Durata Study Site	Rock Island	Illinois
United States	Durata Study Site	Sacramento	California
United States	Durata Study Site	San Diego	California
United States	Durata Study Site	Santa Ana	California
United States	Durata Study Site	Savannah	Georgia
United States	Durata Study Site	Somers Point	New Jersey
United States	Durata Study Site	St. Cloud	Florida
United States	Durata Study Site	Staten Island	New York
United States	Durata Study Site	Sylmar	California
United States	Durata Study Site	Tampa	Florida
United States	Durata Study Site	Toledo	Ohio
United States	Durata Study Site	Torrance	California
United States	Durata Study Site	Upland	California
United States	Durata Study Site	Whittier	California
United States	Durata Study Site	Winston Salem	North Carolina
United States	Durata Study Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Durata Therapeutics Inc., an affiliate of Allergan plc

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  Georgia,  Germany,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Clinical Efficacy	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	48-72 hours after the initiation of study therapy	No
Secondary	>= 20% Reduction in Lesion Area	Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size	48-72 hours after the initiation of study therapy	No
Secondary	Clinical Status	Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics	End of Treatment Visit (Day 14-15)	No
Secondary	Clinical Status	Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics	Follow-Up Visit (day 28)	No