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

Primary Purpose

Abscess, Wound Infection, Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IV Dalbavancin
Vancomycin/Linezolid
Sponsored by
Durata Therapeutics Inc., an affiliate of Allergan plc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study SIte
  • Durata Study Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Clinical Site
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  • Durata Study Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
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  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
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  • Durata Clinical Site
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  • Durata Clinical Site
  • Durata Clinical SIte
  • Durata Clinical Site
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  • Durata Clinical Site
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  • Durata Clinical Site
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  • Durata Study Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Trial
  • Durata Clinical Site
  • Durata Study Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Clinical Trial
  • Durata Study Site
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  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
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  • Durata Clinical Site
  • Durata Study Site
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  • Durata Study Site
  • Durata Study Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
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  • Durata Clinical Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Study Site
  • Durata Clinical Site
  • Durata Study Site
  • Durata Study Site
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  • Durata Clinical Site
  • Durata Study Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vancomycin with possible switch to oral linezolid

Dalbavancin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
>= 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
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

Full Information

First Posted
September 8, 2011
Last Updated
December 27, 2013
Sponsor
Durata Therapeutics Inc., an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT01431339
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durata Therapeutics Inc., an affiliate of Allergan plc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess, Wound Infection, Surgical Site Infection, Cellulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
739 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin with possible switch to oral linezolid
Arm Type
Active Comparator
Arm Title
Dalbavancin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IV Dalbavancin
Intervention Description
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Intervention Type
Drug
Intervention Name(s)
Vancomycin/Linezolid
Intervention Description
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
Primary Outcome Measure Information:
Title
Early Clinical Efficacy
Description
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
Time Frame
After 48-72 hours of therapy
Secondary Outcome Measure Information:
Title
Clinical Status
Description
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
Time Frame
End of Treatment Visit (Day 14-15)
Title
>= 20% Reduction in Lesion Area
Description
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size
Time Frame
48-72 hours after the initiation of study therapy
Title
Clinical Status
Description
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
Time Frame
Follow-Up Visit (day 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients 18 - 85 years of age. Signed and dated informed consent document. Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection. Requires a minimum of 3 days of IV therapy. Patient willing and able to comply with study procedures. Exclusion Criteria: Patients presenting with any of the following: A contra-indication to any required study drug. Pregnant or nursing females. Sustained shock. Participation in another study of an investigational drug or device within 30 days. 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. Infection due to a dalbavancin or vancomycin-resistant organism. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection. Exclusively gram-negative bacterial or a fungal ABSSSI. Venous catheter infection. Infection of a diabetic foot ulcer or a decubitus ulcer. Device-related infections. Gram-negative bacteremia. Infected burns. Infected limb with critical ischemia. Superficial/simple skin and skin structure infections. Concomitant condition requiring non-study antibacterial therapy. ABSSSI requiring therapy for longer than 14 days. Adjunctive therapy with hyperbaric oxygen. More than 2 surgical interventions for ABSSSI anticipated. Chronic inflammatory condition precluding assessment of clinical response. Absolute neutrophil count < 500 cells/mm3. Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3. Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation. Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy. Life expectancy less than 3 months. Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results. Prior participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dunne, MD
Organizational Affiliation
Durata Therapeutics Inc., an affiliate of Allergan plc
Official's Role
Study Director
Facility Information:
Facility Name
Durata Clinical Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Durata Clinical Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Durata Clinical Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Durata Study Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Durata Clinical Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Durata Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Durata Study Site
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Durata Study Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Durata Study SIte
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Durata Study Site
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Durata Clinical Site
City
Boyton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Durata Clinical Site
City
Ft. Meyers
State/Province
Florida
ZIP/Postal Code
33966
Country
United States
Facility Name
Durata Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Durata Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32837
Country
United States
Facility Name
Durata Clinical Site
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Durata Clinical Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Durata Study Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Durata Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Durata Study Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Durata Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Durata Study Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Durata Study Site
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Durata Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Durata Study Site
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45502
Country
United States
Facility Name
Durata Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Durata Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Durata Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Durata Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Durata Study Site
City
Richmond
State/Province
Texas
ZIP/Postal Code
77469
Country
United States
Facility Name
Durata Study Site
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Durata Study Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Durata Study Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Durata Study Site
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Durata Study Site
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Durata Study Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Durata Study Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Durata Study Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Durata Study Site
City
Kohtla-Jarve
ZIP/Postal Code
30322
Country
Estonia
Facility Name
Durata Clinical Site
City
Kohtla-Jarve
Country
Estonia
Facility Name
Durata Clinical Site
City
Tallinn
ZIP/Postal Code
10136
Country
Estonia
Facility Name
Durata Clinical Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Durata Study Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Durata Study Site
City
Budapest
ZIP/Postal Code
H-1081
Country
Hungary
Facility Name
Durata Clinical Site
City
Budapest
Country
Hungary
Facility Name
Durata Study Site
City
Debrecen
ZIP/Postal Code
H-4043
Country
Hungary
Facility Name
Durata Clinical Site
City
Kaposvar
ZIP/Postal Code
H-7400
Country
Hungary
Facility Name
Durata Clinical SIte
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Durata Clinical Site
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Durata Study Site
City
Veszprem
ZIP/Postal Code
H-8200
Country
Hungary
Facility Name
Durata Clinical Site
City
Haifa
ZIP/Postal Code
31906
Country
Israel
Facility Name
Durata Study Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Durata Clinical Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Durata Study Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Durata Clinical Site
City
Petah-Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Durata Clinical Site
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Durata Study Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Durata Clinical Site
City
Jung Gu
State/Province
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Ansan
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Durata Study Site
City
Daejeon
ZIP/Postal Code
301721
Country
Korea, Republic of
Facility Name
Durata Study Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Kangwon-do
ZIP/Postal Code
220-71
Country
Korea, Republic of
Facility Name
Durata Study Site
City
Seoul
ZIP/Postal Code
133-791
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
Durata Study Site
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
Durata Study Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Durata Study Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Durata Clinical Site
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Durata Clinical Site
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
Durata Study Site
City
Rezekne
ZIP/Postal Code
LV-4600
Country
Latvia
Facility Name
Durata Study Site
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Durata Clinical Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Durata Clinical Site
City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Durata Clinical Site
City
Kaunas
ZIP/Postal Code
LT-45130
Country
Lithuania
Facility Name
Durata Clinical Site
City
Kauno m. sav
ZIP/Postal Code
LT-47144
Country
Lithuania
Facility Name
Durata Clinical Site
City
Klaipėda
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Durata Clinical Trial
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
Durata Clinical Site
City
Šiauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Durata Study Site
City
Bucharest
ZIP/Postal Code
010713
Country
Romania
Facility Name
Durata Clinical Site
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Durata Study Site
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Durata Clinical Trial
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
Facility Name
Durata Study Site
City
Bucharest
ZIP/Postal Code
75622
Country
Romania
Facility Name
Durata Clinical Site
City
Burcharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Durata Study Site
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Durata Study Site
City
Constanta
ZIP/Postal Code
900709
Country
Romania
Facility Name
Durata Study Site
City
Targu Mures
ZIP/Postal Code
540072
Country
Romania
Facility Name
Durata Clinical Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Durata Clinical Site
City
Vsevolozhsk
State/Province
Leningrad Region
ZIP/Postal Code
188640
Country
Russian Federation
Facility Name
Durata Study Site
City
Vsevolozhsk
State/Province
Leningrad
ZIP/Postal Code
188864
Country
Russian Federation
Facility Name
Durata Study Site
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Durata Clinical Site
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Durata Study Site
City
Petrozavodsk
ZIP/Postal Code
18519
Country
Russian Federation
Facility Name
Durata Clinical Site
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Durata Clinical Site
City
St. Petersburg
ZIP/Postal Code
198099
Country
Russian Federation
Facility Name
Durata Study Site
City
Tomsk
Country
Russian Federation
Facility Name
Durata Clinical Site
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Durata Clinical Site
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Durata Clinical Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Durata Clinical Site
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Durata Clinical Site
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Durata Clinical Site
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Durata Clinical Site
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Durata Study Site
City
KwaZulu
State/Province
Durban
ZIP/Postal Code
4037
Country
South Africa
Facility Name
Durata Study Site
City
KwaZulu-Natal
State/Province
Ladysmieth
ZIP/Postal Code
3370
Country
South Africa
Facility Name
Durata Study Site
City
Mpumalanga
State/Province
Middleburg
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Durata Study Site
City
Mpekweni
State/Province
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Durata Study Site
City
Western Cape
State/Province
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Durata Clinical Site
City
Gauteng
State/Province
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Durata Study Site
City
Gauteng
State/Province
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Durata Study Site
City
Johannesburg
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Durata Study Site
City
Port Elizabeth
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Durata Study Site
City
Port Elizabeth
ZIP/Postal Code
6070
Country
South Africa
Facility Name
Durata Clinical Site
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Durata Study Site
City
Thabazimbi
ZIP/Postal Code
0380
Country
South Africa
Facility Name
Durata Study Site
City
Tainan
State/Province
Fukien
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Durata Study Site
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Durata Study Site
City
Kaohsiung
ZIP/Postal Code
ROC 807
Country
Taiwan
Facility Name
Durata Clinical Site
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Durata Clinical Site
City
Taipai
Country
Taiwan
Facility Name
Durata Study Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Durata Study Site
City
Yung Kang City
ZIP/Postal Code
71044
Country
Taiwan
Facility Name
Durata Study Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Durata Study Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Durata Study Site
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
Durata Clinical Site
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Durata Study Site
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Durata Study Site
City
Ivano-Frankivsk
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Durata Study Site
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Durata Clinical Site
City
Kyiv
ZIP/Postal Code
02666
Country
Ukraine
Facility Name
Durata Study Site
City
Kyiv
ZIP/Postal Code
02666
Country
Ukraine
Facility Name
Durata Study Site
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Durata Study Site
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Durata Study Site
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Durata Study Site
City
Zaporizhia
ZIP/Postal Code
69032
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34905144
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.
Results Reference
derived
PubMed Identifier
24897082
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.
Results Reference
derived

Learn more about this trial

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

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