Clinical trial NCT01339091: 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 Regiment (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: 2011-04-20
Enrollment: 573
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 proven gram-positive bacterial skin or skin structure infection.


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: 48-72 hours after the initiation of study therapy
Secondary outcomes:
measure: >= 20% Reduction in Lesion Area
timeFrame: 48-72 hours after the initiation of study therapy
measure: Clinical Status
timeFrame: End of Treatment Visit (Day 14-15)
measure: Clinical Status
timeFrame: Follow-Up Visit (day 28)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Durata Study Site
state: California
city: Azusa
country: United States
facility: Durata Study Site
state: California
city: Bellflower
country: United States
facility: Durata Study Site
state: California
city: Buena Park
country: United States
facility: Durata Study Site
state: California
city: Carmel
country: United States
facility: Durata Study Site
state: California
city: Chula Vista
country: United States
facility: Durata Study Site
state: California
city: Covina
country: United States
facility: Durata Study Site
state: California
city: Fountain Valley
country: United States
facility: Durata Study Site
state: California
city: La Mesa
country: United States
facility: Durata Study Site
state: California
city: Long Beach
country: United States
facility: Durata Study Site
state: California
city: Los Alamitos
country: United States
facility: Durata Study Site
state: California
city: Los Angeles
country: United States
facility: Durata Study Site
state: California
city: Oceanside
country: United States
facility: Durata Study Site
state: California
city: Palm Desert
country: United States
facility: Durata Study Site
state: California
city: Pasadena
country: United States
facility: Durata Study Site
state: California
city: Sacramento
country: United States
facility: Durata Study Site
state: California
city: San Diego
country: United States
facility: Durata Study Site
state: California
city: Santa Ana
country: United States
facility: Durata Study Site
state: California
city: Sylmar
country: United States
facility: Durata Study Site
state: California
city: Torrance
country: United States
facility: Durata Study Site
state: California
city: Upland
country: United States
facility: Durata Study Site
state: California
city: Whittier
country: United States
facility: Durata Study Site
state: California
city: Miami
country: United States
facility: Durata Study Site
state: Florida
city: Miami
country: United States
facility: Durata Study Site
state: Florida
city: Orlando
country: United States
facility: Durata Study Site
state: Florida
city: St. Cloud
country: United States
facility: Durata Study Site
state: Florida
city: Tampa
country: United States
facility: Durata Study Site
state: Florida
city: Columbus
country: United States
facility: Durata Study Site
state: Georgia
city: Savannah
country: United States
facility: Durata Study Site
state: Georgia
city: Idaho Falls
country: United States
facility: Durata Study Site
state: Idaho
city: Pocatello
country: United States
facility: Durata Study Site
state: Idaho
city: Moline
country: United States
facility: Durata Study Site
state: Illinois
city: Rock Island
country: United States
facility: Durata Study Site
state: Illinois
city: Baton Rouge
country: United States
facility: Durata Study Site
state: Louisiana
city: Lafayette
country: United States
facility: Durata Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Durata Clinical Site
state: Louisiana
city: Opelousas
country: United States
facility: Durata Study Site
state: Louisiana
city: Detroit
country: United States
facility: Durata Study Site
state: Michigan
city: Minneapolis
country: United States
facility: Durata Study Site
state: Minnesota
city: Las Vegas
country: United States
facility: Durata Study Site
state: Nevada
city: Somers Point
country: United States
facility: Durata Study Site
state: New Jersey
city: Bronx
country: United States
facility: Durata Study Site
state: New York
city: Buffalo
country: United States
facility: Durata Study Site
state: New York
city: Lake Success
country: United States
facility: Durata Study Site
state: New York
city: New Hyde Park
country: United States
facility: Durata Study Site
state: New York
city: Staten Island
country: United States
facility: Durata Study Site
state: New York
city: Winston Salem
country: United States
facility: Durata Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Durata Study Site
state: North Carolina
city: Columbus
country: United States
facility: Durata Study Site
state: Ohio
city: Lima
country: United States
facility: Durata Study Site
state: Ohio
city: Toledo
country: United States
facility: Durata Study Site
state: Ohio
city: Pittsburgh
country: United States
facility: Durata Study Site
state: Pennsylvania
city: Houston
country: United States
facility: Durata Study Site
state: Texas
city: Houston
country: United States
facility: Durata Study Site
state: Texas
city: Madison
country: United States
facility: Durata Study Site
state: Wisconsin
city: Middleton
country: United States
facility: Durata Study Site
state: Wisconsin
city: Winnipeg
country: Canada
facility: Durata Study Site
state: Manitoba
city: Trois-Rivieres
country: Canada
facility: Durata Study Site
state: Quebec
city: Dubrovnik
country: Croatia
facility: Durata Study Site
city: Slavonski Brod
country: Croatia
facility: Durata Clinical Site
city: Zagreb
country: Croatia
facility: Durata Study Site
city: Zagreb
country: Croatia
facility: Durata Study Site
city: Tbilisi
country: Georgia
facility: Durata Clinical Site
city: Bochum
country: Germany
facility: Durata Study Site
city: Munster
country: Germany
facility: Durata Study Site
city: Krakow
country: Poland
facility: Durata Study Site
city: Legionowo
country: Poland
facility: Durata Study Site
city: Warszawa
country: Poland
facility: Durata Study Site
city: Wroclaw
country: Poland
facility: Durata Study Site
city: Kharkiv
country: Russian Federation
facility: Durata Study Site
state: Ukraine
city: Kyiv city
country: Russian Federation
facility: Durata Study Site
state: Ukraine
city: Ekaterinburg
country: Russian Federation
facility: Durata Study Site
city: Moscow
country: Russian Federation
facility: Durata Study Site
city: Moscow
country: Russian Federation
facility: Durata Clinical Site
city: Moscow
country: Russian Federation
facility: Durata Study Site
city: Perm
country: Russian Federation
facility: Durata Study Site
city: Saratov
country: Russian Federation
facility: Durata Study Site
city: Smolensk
country: Russian Federation
facility: Durata Study Site
city: St. Petersburg
country: Russian Federation
facility: Durata Study Site
city: St. Petersburg
country: Russian Federation
facility: Durata Study Site
city: St. Petersburg
country: Russian Federation
facility: Durata Study Site
city: St. Petersburg
country: Russian Federation
facility: Durata Study Site
city: St. Petersburg
country: Russian Federation
facility: Durata Clinical Site
city: Tomsk
country: Russian Federation
facility: Durata Study Site
city: Cherkasy
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 Study Site
city: Kyiv
country: Ukraine
facility: Durata Study Site
city: Uzhgorod
country: Ukraine
facility: Durata Study Site
city: Zaporizhzhya
country: Ukraine
facility: Durata Study Site
city: Zhytomyr
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.