Clinical trial NCT01431339: Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abscess
Wound Infection
Surgical Site Infection
Cellulitis
Lead sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2011-09-09
Enrollment: 739
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Early Clinical Efficacy
timeFrame: After 48-72 hours of therapy
Secondary outcomes:
measure: Clinical Status
timeFrame: End of Treatment Visit (Day 14-15)
measure: >= 20% Reduction in Lesion Area
timeFrame: 48-72 hours after the initiation of study therapy
measure: Clinical Status
timeFrame: Follow-Up Visit (day 28)
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Durata Clinical Site
state: Alabama
city: Anaheim
country: United States
facility: Durata Clinical Site
state: California
city: Buena Park
country: United States
facility: Durata Clinical Site
state: California
city: Chula Vista
country: United States
facility: Durata Study Site
state: California
city: Long Beach
country: United States
facility: Durata Clinical Site
state: California
city: Los Angeles
country: United States
facility: Durata Study Site
state: California
city: Norwalk
country: United States
facility: Durata Study Site
state: California
city: Oxnard
country: United States
facility: Durata Study Site
state: California
city: San Diego
country: United States
facility: Durata Study SIte
state: California
city: Stockton
country: United States
facility: Durata Study Site
state: California
city: Boyton Beach
country: United States
facility: Durata Clinical Site
state: Florida
city: Ft. Meyers
country: United States
facility: Durata Clinical Site
state: Florida
city: Miami
country: United States
facility: Durata Clinical Site
state: Florida
city: Orlando
country: United States
facility: Durata Study Site
state: Florida
city: St. Cloud
country: United States
facility: Durata Clinical Site
state: Florida
city: Augusta
country: United States
facility: Durata Clinical Site
state: Georgia
city: Columbus
country: United States
facility: Durata Study Site
state: Georgia
city: Chicago
country: United States
facility: Durata Clinical Site
state: Illinois
city: Baton Rouge
country: United States
facility: Durata Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Durata Study Site
state: Louisiana
city: Shreveport
country: United States
facility: Durata Study Site
state: Louisiana
city: Zachary
country: United States
facility: Durata Study Site
state: Louisiana
city: Las Vegas
country: United States
facility: Durata Study Site
state: Nevada
city: Springfield
country: United States
facility: Durata Study Site
state: Ohio
city: Philadelphia
country: United States
facility: Durata Study Site
state: Pennsylvania
city: Austin
country: United States
facility: Durata Study Site
state: Texas
city: Austin
country: United States
facility: Durata Clinical Site
state: Texas
city: Houston
country: United States
facility: Durata Clinical Site
state: Texas
city: Richmond
country: United States
facility: Durata Study Site
state: Texas
city: Middleton
country: United States
facility: Durata Study Site
state: Wisconsin
city: Pleven
country: Bulgaria
facility: Durata Study Site
city: Plovdiv
country: Bulgaria
facility: Durata Study Site
city: Sevlievo
country: Bulgaria
facility: Durata Study Site
city: Sofia
country: Bulgaria
facility: Durata Study Site
city: Sofia
country: Bulgaria
facility: Durata Study Site
city: Sofia
country: Bulgaria
facility: Durata Study Site
city: Sofia
country: Bulgaria
facility: Durata Study Site
city: Kohtla-Jarve
country: Estonia
facility: Durata Study Site
city: Kohtla-Jarve
country: Estonia
facility: Durata Clinical Site
city: Tallinn
country: Estonia
facility: Durata Clinical Site
city: Tallinn
country: Estonia
facility: Durata Clinical Site
city: Tartu
country: Estonia
facility: Durata Study Site
city: Budapest
country: Hungary
facility: Durata Study Site
city: Budapest
country: Hungary
facility: Durata Clinical Site
city: Debrecen
country: Hungary
facility: Durata Study Site
city: Kaposvar
country: Hungary
facility: Durata Clinical Site
city: Pecs
country: Hungary
facility: Durata Clinical SIte
city: Szeged
country: Hungary
facility: Durata Clinical Site
city: Veszprem
country: Hungary
facility: Durata Study Site
city: Haifa
country: Israel
facility: Durata Clinical Site
city: Jerusalem
country: Israel
facility: Durata Study Site
city: Kfar Saba
country: Israel
facility: Durata Clinical Site
city: Petach Tikva
country: Israel
facility: Durata Study Site
city: Petah-Tiqva
country: Israel
facility: Durata Clinical Site
city: Ramat-Gan
country: Israel
facility: Durata Clinical Site
city: Tel Aviv
country: Israel
facility: Durata Study Site
city: Jung Gu
country: Korea, Republic of
facility: Durata Clinical Site
state: Daegu
city: Ansan
country: Korea, Republic of
facility: Durata Clinical Site
city: Daejeon
country: Korea, Republic of
facility: Durata Study Site
city: Gwangju
country: Korea, Republic of
facility: Durata Study Site
city: Incheon
country: Korea, Republic of
facility: Durata Clinical Site
city: Kangwon-do
country: Korea, Republic of
facility: Durata Clinical Site
city: Seoul
country: Korea, Republic of
facility: Durata Study Site
city: Seoul
country: Korea, Republic of
facility: Durata Clinical Site
city: Seoul
country: Korea, Republic of
facility: Durata Study Site
city: Seoul
country: Korea, Republic of
facility: Durata Study Site
city: Seoul
country: Korea, Republic of
facility: Durata Clinical Site
city: Seoul
country: Korea, Republic of
facility: Durata Study Site
city: Seoul
country: Korea, Republic of
facility: Durata Clinical Site
city: Daugavpils
country: Latvia
facility: Durata Clinical Site
city: Liepaja
country: Latvia
facility: Durata Clinical Site
city: Rezekne
country: Latvia
facility: Durata Study Site
city: Riga
country: Latvia
facility: Durata Study Site
city: Riga
country: Latvia
facility: Durata Clinical Site
city: Ventspils
country: Latvia
facility: Durata Clinical Site
city: Kaunas
country: Lithuania
facility: Durata Clinical Site
city: Kauno m. sav
country: Lithuania
facility: Durata Clinical Site
city: Klaipėda
country: Lithuania
facility: Durata Clinical Site
city: Vilnius
country: Lithuania
facility: Durata Clinical Trial
city: Šiauliai
country: Lithuania
facility: Durata Clinical Site
city: Bucharest
country: Romania
facility: Durata Study Site
city: Bucharest
country: Romania
facility: Durata Clinical Site
city: Bucharest
country: Romania
facility: Durata Study Site
city: Bucharest
country: Romania
facility: Durata Clinical Trial
city: Bucharest
country: Romania
facility: Durata Study Site
city: Burcharest
country: Romania
facility: Durata Clinical Site
city: Cluj-Napoca
country: Romania
facility: Durata Study Site
city: Constanta
country: Romania
facility: Durata Study Site
city: Targu Mures
country: Romania
facility: Durata Study Site
city: Timisoara
country: Romania
facility: Durata Clinical Site
city: Vsevolozhsk
country: Russian Federation
facility: Durata Clinical Site
state: Leningrad Region
city: Vsevolozhsk
country: Russian Federation
facility: Durata Study Site
state: Leningrad
city: Moscow
country: Russian Federation
facility: Durata Study Site
city: Moscow
country: Russian Federation
facility: Durata Clinical Site
city: Petrozavodsk
country: Russian Federation
facility: Durata Study Site
city: Smolensk
country: Russian Federation
facility: Durata Clinical Site
city: St. Petersburg
country: Russian Federation
facility: Durata Clinical Site
city: Tomsk
country: Russian Federation
facility: Durata Study Site
city: Tver
country: Russian Federation
facility: Durata Clinical Site
city: Volgograd
country: Russian Federation
facility: Durata Clinical Site
city: Yaroslavl
country: Russian Federation
facility: Durata Clinical Site
city: Banska Bystrica
country: Slovakia
facility: Durata Clinical Site
city: Levice
country: Slovakia
facility: Durata Clinical Site
city: Nitra
country: Slovakia
facility: Durata Clinical Site
city: Svidnik
country: Slovakia
facility: Durata Clinical Site
city: KwaZulu
country: South Africa
facility: Durata Study Site
state: Durban
city: KwaZulu-Natal
country: South Africa
facility: Durata Study Site
state: Ladysmieth
city: Mpumalanga
country: South Africa
facility: Durata Study Site
state: Middleburg
city: Mpekweni
country: South Africa
facility: Durata Study Site
state: Paarl
city: Western Cape
country: South Africa
facility: Durata Study Site
state: Paarl
city: Gauteng
country: South Africa
facility: Durata Clinical Site
state: Pretoria
city: Gauteng
country: South Africa
facility: Durata Study Site
state: Soweto
city: Johannesburg
country: South Africa
facility: Durata Study Site
city: Port Elizabeth
country: South Africa
facility: Durata Study Site
city: Port Elizabeth
country: South Africa
facility: Durata Study Site
city: Pretoria
country: South Africa
facility: Durata Clinical Site
city: Thabazimbi
country: South Africa
facility: Durata Study Site
city: Tainan
country: Taiwan
facility: Durata Study Site
state: Fukien
city: Kaohsiung
country: Taiwan
facility: Durata Study Site
city: Kaohsiung
country: Taiwan
facility: Durata Study Site
city: Taichung City
country: Taiwan
facility: Durata Clinical Site
city: Taipai
country: Taiwan
facility: Durata Clinical Site
city: Taipei
country: Taiwan
facility: Durata Study Site
city: Yung Kang City
country: Taiwan
facility: Durata Study Site
city: Cherkasy
country: Ukraine
facility: Durata Study Site
city: Dnipropetrovsk
country: Ukraine
facility: Durata Study Site
city: Donetsk
country: Ukraine
facility: Durata Study Site
city: Ivano-Frankivsk
country: Ukraine
facility: Durata Clinical Site
city: Ivano-Frankivsk
country: Ukraine
facility: Durata Study Site
city: Ivano-Frankivsk
country: Ukraine
facility: Durata Study Site
city: Kharkiv
country: Ukraine
facility: Durata Study Site
city: Kyiv
country: Ukraine
facility: Durata Clinical Site
city: Kyiv
country: Ukraine
facility: Durata Study Site
city: Lviv
country: Ukraine
facility: Durata Study Site
city: Lviv
country: Ukraine
facility: Durata Study Site
city: Uzhhorod
country: Ukraine
facility: Durata Study Site
city: Zaporizhia
country: Ukraine
facility: Durata Study Site
Study officials:
affiliation: Durata Therapeutics Inc., an affiliate of Allergan plc
name: Michael Dunne, MD
role: STUDY_DIRECTOR
References:
citation: Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.
citation: Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.