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 Regimen (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431339
• Other study ID #: DUR001-302
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2011
• Last updated: December 27, 2013
• Start date: July 2011
• Est. completion date: December 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 proved gram-positive bacterial skin or skin structure infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: December 2012
• Est. primary completion date: November 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:
• IV 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 every 12 hours). Total duration of therapy is 10-14 days

Locations

Country	Name	City	State
Bulgaria	Durata Study Site	Pleven
Bulgaria	Durata Study Site	Plovdiv
Bulgaria	Durata Study Site	Sevlievo
Bulgaria	Durata Study Site	Sofia
Bulgaria	Durata Study Site	Sofia
Bulgaria	Durata Study Site	Sofia
Bulgaria	Durata Study Site	Sofia
Estonia	Durata Clinical Site	Kohtla-Jarve
Estonia	Durata Study Site	Kohtla-Jarve
Estonia	Durata Clinical Site	Tallinn
Estonia	Durata Clinical Site	Tallinn
Estonia	Durata Study Site	Tartu
Hungary	Durata Clinical Site	Budapest
Hungary	Durata Study Site	Budapest
Hungary	Durata Study Site	Debrecen
Hungary	Durata Clinical Site	Kaposvar
Hungary	Durata Clinical SIte	Pecs
Hungary	Durata Clinical Site	Szeged
Hungary	Durata Study Site	Veszprem
Israel	Durata Clinical Site	Haifa
Israel	Durata Study Site	Jerusalem
Israel	Durata Clinical Site	Kfar Saba
Israel	Durata Study Site	Petach Tikva
Israel	Durata Clinical Site	Petah-Tiqva
Israel	Durata Clinical Site	Ramat-Gan
Israel	Durata Study Site	Tel Aviv
Korea, Republic of	Durata Clinical Site	Ansan
Korea, Republic of	Durata Study Site	Daejeon
Korea, Republic of	Durata Study Site	Gwangju
Korea, Republic of	Durata Clinical Site	Incheon
Korea, Republic of	Durata Clinical Site	Jung Gu	Daegu
Korea, Republic of	Durata Clinical Site	Kangwon-do
Korea, Republic of	Durata Clinical Site	Seoul
Korea, Republic of	Durata Clinical Site	Seoul
Korea, Republic of	Durata Clinical Site	Seoul
Korea, Republic of	Durata Study Site	Seoul
Korea, Republic of	Durata Study Site	Seoul
Korea, Republic of	Durata Study Site	Seoul
Korea, Republic of	Durata Study Site	Seoul
Latvia	Durata Clinical Site	Daugavpils
Latvia	Durata Clinical Site	Liepaja
Latvia	Durata Study Site	Rezekne
Latvia	Durata Clinical Site	Riga
Latvia	Durata Study Site	Riga
Latvia	Durata Clinical Site	Ventspils
Lithuania	Durata Clinical Site	Šiauliai
Lithuania	Durata Clinical Site	Kaunas
Lithuania	Durata Clinical Site	Kauno m. sav
Lithuania	Durata Clinical Site	Klaipeda
Lithuania	Durata Clinical Trial	Vilnius
Romania	Durata Clinical Site	Bucharest
Romania	Durata Clinical Trial	Bucharest
Romania	Durata Study Site	Bucharest
Romania	Durata Study Site	Bucharest
Romania	Durata Study Site	Bucharest
Romania	Durata Clinical Site	Burcharest
Romania	Durata Study Site	Cluj-Napoca
Romania	Durata Study Site	Constanta
Romania	Durata Study Site	Targu Mures
Romania	Durata Clinical Site	Timisoara
Russian Federation	Durata Clinical Site	Moscow
Russian Federation	Durata Study Site	Moscow
Russian Federation	Durata Study Site	Petrozavodsk
Russian Federation	Durata Clinical Site	Smolensk
Russian Federation	Durata Clinical Site	St. Petersburg
Russian Federation	Durata Study Site	Tomsk
Russian Federation	Durata Clinical Site	Tver
Russian Federation	Durata Clinical Site	Volgograd
Russian Federation	Durata Clinical Site	Vsevolozhsk	Leningrad Region
Russian Federation	Durata Study Site	Vsevolozhsk	Leningrad
Russian Federation	Durata Clinical Site	Yaroslavl
Slovakia	Durata Clinical Site	Banska Bystrica
Slovakia	Durata Clinical Site	Levice
Slovakia	Durata Clinical Site	Nitra
Slovakia	Durata Clinical Site	Svidnik
South Africa	Durata Clinical Site	Gauteng	Pretoria
South Africa	Durata Study Site	Gauteng	Soweto
South Africa	Durata Study Site	Johannesburg
South Africa	Durata Study Site	KwaZulu	Durban
South Africa	Durata Study Site	KwaZulu-Natal	Ladysmieth
South Africa	Durata Study Site	Mpekweni	Paarl
South Africa	Durata Study Site	Mpumalanga	Middleburg
South Africa	Durata Study Site	Port Elizabeth
South Africa	Durata Study Site	Port Elizabeth
South Africa	Durata Clinical Site	Pretoria
South Africa	Durata Study Site	Thabazimbi
South Africa	Durata Study Site	Western Cape	Paarl
Taiwan	Durata Study Site	Kaohsiung
Taiwan	Durata Study Site	Kaohsiung
Taiwan	Durata Clinical Site	Taichung City
Taiwan	Durata Study Site	Tainan	Fukien
Taiwan	Durata Clinical Site	Taipai
Taiwan	Durata Study Site	Taipei
Taiwan	Durata Study Site	Yung Kang City
Ukraine	Durata Study Site	Cherkasy
Ukraine	Durata Study Site	Dnipropetrovsk
Ukraine	Durata Study Site	Donetsk
Ukraine	Durata Clinical Site	Ivano-Frankivsk
Ukraine	Durata Study Site	Ivano-Frankivsk
Ukraine	Durata Study Site	Ivano-Frankivsk
Ukraine	Durata Study Site	Kharkiv
Ukraine	Durata Clinical Site	Kyiv
Ukraine	Durata Study Site	Kyiv
Ukraine	Durata Study Site	Lviv
Ukraine	Durata Study Site	Lviv
Ukraine	Durata Study Site	Uzhhorod
Ukraine	Durata Study Site	Zaporizhia
United States	Durata Clinical Site	Anaheim	California
United States	Durata Clinical Site	Augusta	Georgia
United States	Durata Clinical Site	Austin	Texas
United States	Durata Study Site	Austin	Texas
United States	Durata Study Site	Baton Rouge	Louisiana
United States	Durata Clinical Site	Boyton Beach	Florida
United States	Durata Clinical Site	Buena Park	California
United States	Durata Clinical Site	Chicago	Illinois
United States	Durata Study Site	Chula Vista	California
United States	Durata Study Site	Columbus	Georgia
United States	Durata Clinical Site	Ft. Meyers	Florida
United States	Durata Clinical Site	Houston	Texas
United States	Durata Study Site	Las Vegas	Nevada
United States	Durata Clinical Site	Long Beach	California
United States	Durata Study Site	Los Angeles	California
United States	Durata Clinical Site	Miami	Florida
United States	Durata Study Site	Middleton	Wisconsin
United States	Durata Clinical Site	Montgomery	Alabama
United States	Durata Study Site	New Orleans	Louisiana
United States	Durata Study Site	Norwalk	California
United States	Durata Study Site	Orlando	Florida
United States	Durata Study Site	Oxnard	California
United States	Durata Study Site	Philadelphia	Pennsylvania
United States	Durata Study Site	Richmond	Texas
United States	Durata Study SIte	San Diego	California
United States	Durata Study Site	Shreveport	Louisiana
United States	Durata Study Site	Springfield	Ohio
United States	Durata Clinical Site	St. Cloud	Florida
United States	Durata Study Site	Stockton	California
United States	Durata Study Site	Zachary	Louisiana

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Bulgaria,  Estonia,  Hungary,  Israel,  Korea, Republic of,  Latvia,  Lithuania,  Romania,  Russian Federation,  Slovakia,  South Africa,  Taiwan,  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	After 48-72 hours of 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 other therapy	End of Treatment Visit (Day 14-15)	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 the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy	Follow-Up Visit (day 28)	No