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

PHASE3CompletedINTERVENTIONAL
Enrollment

739

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

December 31, 2012

Conditions
AbscessWound InfectionSurgical Site InfectionCellulitis
Interventions
DRUG

IV Dalbavancin

IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

DRUG

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

Trial Locations (137)

813

Durata Study Site, Kaohsiung City

1000

Durata Study Site, Sofia

1055

Durata Study Site, Mpumalanga

1407

Durata Study Site, Sofia

1431

Durata Study Site, Sofia

1500

Durata Study Site, Johannesburg

1606

Durata Study Site, Sofia

2013

Durata Study Site, Gauteng

3370

Durata Study Site, KwaZulu-Natal

4000

Durata Study Site, Plovdiv

4037

Durata Study Site, KwaZulu

5400

Durata Study Site, Sevlievo

5800

Durata Study Site, Pleven

6014

Durata Study Site, Port Elizabeth

6070

Durata Study Site, Port Elizabeth

7646

Durata Study Site, Mpekweni

Durata Study Site, Western Cape

10002

Durata Study Site, Taipei

10136

Durata Clinical Site, Tallinn

13419

Durata Clinical Site, Tallinn

18009

Durata Study Site, Cherkasy

18519

Durata Study Site, Petrozavodsk

19103

Durata Study Site, Philadelphia

30322

Durata Study Site, Kohtla-Järve

30901

Durata Clinical Site, Augusta

31904

Durata Study Site, Columbus

31906

Durata Clinical Site, Haifa

32837

Durata Study Site, Orlando

33015

Durata Clinical Site, Miami

33435

Durata Clinical Site, Boyton Beach

33966

Durata Clinical Site, Fort Meyers

34769

Durata Clinical Site, Saint Cloud

36106

Durata Clinical Site, Montgomery

40447

Durata Clinical Site, Taichung

44281

Durata Clinical Site, Kfar Saba

45502

Durata Study Site, Springfield

49005

Durata Study Site, Dnipropetrovsk

49100

Durata Clinical Site, Petah Tikva

Durata Study Site, Petah Tikva

51014

Durata Study Site, Tartu

52621

Durata Clinical Site, Ramat Gan

53562

Durata Study Site, Middleton

60637

Durata Clinical Site, Chicago

61058

Durata Study Site, Kharkiv

64239

Durata Study Site, Tel Aviv

69032

Durata Study Site, Zaporizhia

70112

Durata Study Site, New Orleans

70403

Durata Study Site, Tainan

70791

Durata Study Site, Zachary

70809

Durata Study Site, Baton Rouge

71044

Durata Study Site, Yung Kang City

71101

Durata Study Site, Shreveport

75622

Durata Study Site, Bucharest

76014

Durata Clinical Site, Ivano-Frankivsk

Durata Study Site, Ivano-Frankivsk

76025

Durata Study Site, Ivano-Frankivsk

77055

Durata Clinical Site, Houston

77469

Durata Study Site, Richmond

78701

Durata Study Site, Austin

78752

Durata Clinical Site, Austin

79013

Durata Study Site, Lviv

79059

Durata Study Site, Lviv

83099

Durata Study Site, Donetsk

88000

Durata Study Site, Uzhhorod

89109

Durata Study Site, Las Vegas

90015

Durata Study Site, Los Angeles

90620

Durata Clinical Site, Buena Park

90650

Durata Study Site, Norwalk

90813

Durata Clinical Site, Long Beach

91120

Durata Study Site, Jerusalem

91911

Durata Study Site, Chula Vista

92120

Durata Study SIte, San Diego

92804

Durata Clinical Site, Anaheim

93030

Durata Study Site, Oxnard

95204

Durata Study Site, Stockton

111539

Durata Study Site, Moscow

115280

Durata Clinical Site, Moscow

150003

Durata Clinical Site, Yaroslavl

170036

Durata Clinical Site, Tver'

188640

Durata Clinical Site, Vsevolozhsk

188864

Durata Study Site, Vsevolozhsk

198099

Durata Clinical Site, Saint Petersburg

214018

Durata Clinical Site, Smolensk

300736

Durata Clinical Site, Timișoara

301721

Durata Study Site, Daejeon

400006

Durata Study Site, Cluj-Napoca

400138

Durata Clinical Site, Volgograd

540072

Durata Study Site, Târgu Mureş

900709

Durata Study Site, Constanța

Unknown

Durata Clinical Site, Kohtla-Järve

Durata Clinical Site, Budapest

Durata Study Site, Tomsk

Durata Clinical Site, Taipai

H-1081

Durata Study Site, Budapest

H-4043

Durata Study Site, Debrecen

H-7400

Durata Clinical Site, Kaposvár

H-7624

Durata Clinical SIte, Pécs

H-6720

Durata Clinical Site, Szeged

H-8200

Durata Study Site, Veszprém

LV-5417

Durata Clinical Site, Daugavpils

LV-3414

Durata Clinical Site, Liepāja

LV-4600

Durata Study Site, Rēzekne

LV-1001

Durata Study Site, Riga

LV-1002

Durata Clinical Site, Riga

LV-3601

Durata Clinical Site, Ventspils

LT-45130

Durata Clinical Site, Kaunas

LT-47144

Durata Clinical Site, Kauno M. Sav

LT-76231

Durata Clinical Site, Klaipėda

Durata Clinical Site, Šiauliai

LT-10207

Durata Clinical Trial, Vilnius

010713

Durata Study Site, Bucharest

010825

Durata Clinical Site, Bucharest

011461

Durata Study Site, Bucharest

042122

Durata Clinical Trial, Bucharest

020125

Durata Clinical Site, Burcharest

975 17

Durata Clinical Site, Banská Bystrica

934 01

Durata Clinical Site, Levice

950 01

Durata Clinical Site, Nitra

089 01

Durata Clinical Site, Svidník

0001

Durata Clinical Site, Gauteng

0084

Durata Clinical Site, Pretoria

0380

Durata Study Site, Thabazimbi

700-721

Durata Clinical Site, Jung Gu

425-707

Durata Clinical Site, Ansan

501-757

Durata Study Site, Gwangju

405-760

Durata Clinical Site, Incheon

220-71

Durata Clinical Site, Kangwon-do

133-791

Durata Study Site, Seoul

134-701

Durata Clinical Site, Seoul

Durata Study Site, Seoul

135-710

Durata Study Site, Seoul

136-705

Durata Clinical Site, Seoul

138-736

Durata Study Site, Seoul

152-703

Durata Clinical Site, Seoul

ROC 807

Durata Study Site, Kaohsiung City

02666

Durata Clinical Site, Kyiv

Durata Study Site, Kyiv

All Listed Sponsors
lead

Durata Therapeutics Inc., an affiliate of Allergan plc

INDUSTRY

NCT01431339 - Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections | Biotech Hunter | Biotech Hunter