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

• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01431339
• Collaborator: (none)
• Enrollment: 739
• Locations: 137
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abscess; Wound Infection; Surgical Site Infection; Cellulitis	Drug: IV Dalbavancin; Drug: Vancomycin/Linezolid	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 739 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vancomycin with possible switch to oral linezolid	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
Experimental: Dalbavancin	Drug: IV Dalbavancin; IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

Outcome Measures

Primary Outcome Measures

1. Early Clinical Efficacy [After 48-72 hours of therapy]

   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

1. Clinical Status [End of Treatment Visit (Day 14-15)]

   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

2. >= 20% Reduction in Lesion Area [48-72 hours after the initiation of study therapy]

   Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size

3. Clinical Status [Follow-Up Visit (day 28)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durata Clinical Site	Montgomery	Alabama	United States	36106
2	Durata Clinical Site	Anaheim	California	United States	92804
3	Durata Clinical Site	Buena Park	California	United States	90620
4	Durata Study Site	Chula Vista	California	United States	91911
5	Durata Clinical Site	Long Beach	California	United States	90813
6	Durata Study Site	Los Angeles	California	United States	90015
7	Durata Study Site	Norwalk	California	United States	90650
8	Durata Study Site	Oxnard	California	United States	93030
9	Durata Study SIte	San Diego	California	United States	92120
10	Durata Study Site	Stockton	California	United States	95204
11	Durata Clinical Site	Boyton Beach	Florida	United States	33435
12	Durata Clinical Site	Ft. Meyers	Florida	United States	33966
13	Durata Clinical Site	Miami	Florida	United States	33015
14	Durata Study Site	Orlando	Florida	United States	32837
15	Durata Clinical Site	St. Cloud	Florida	United States	34769
16	Durata Clinical Site	Augusta	Georgia	United States	30901
17	Durata Study Site	Columbus	Georgia	United States	31904
18	Durata Clinical Site	Chicago	Illinois	United States	60637
19	Durata Study Site	Baton Rouge	Louisiana	United States	70809
20	Durata Study Site	New Orleans	Louisiana	United States	70112
21	Durata Study Site	Shreveport	Louisiana	United States	71101
22	Durata Study Site	Zachary	Louisiana	United States	70791
23	Durata Study Site	Las Vegas	Nevada	United States	89109
24	Durata Study Site	Springfield	Ohio	United States	45502
25	Durata Study Site	Philadelphia	Pennsylvania	United States	19103
26	Durata Study Site	Austin	Texas	United States	78701
27	Durata Clinical Site	Austin	Texas	United States	78752
28	Durata Clinical Site	Houston	Texas	United States	77055
29	Durata Study Site	Richmond	Texas	United States	77469
30	Durata Study Site	Middleton	Wisconsin	United States	53562
31	Durata Study Site	Pleven		Bulgaria	5800
32	Durata Study Site	Plovdiv		Bulgaria	4000
33	Durata Study Site	Sevlievo		Bulgaria	5400
34	Durata Study Site	Sofia		Bulgaria	1000
35	Durata Study Site	Sofia		Bulgaria	1407
36	Durata Study Site	Sofia		Bulgaria	1431
37	Durata Study Site	Sofia		Bulgaria	1606
38	Durata Study Site	Kohtla-Jarve		Estonia	30322
39	Durata Clinical Site	Kohtla-Jarve		Estonia
40	Durata Clinical Site	Tallinn		Estonia	10136
41	Durata Clinical Site	Tallinn		Estonia	13419
42	Durata Study Site	Tartu		Estonia	51014
43	Durata Study Site	Budapest		Hungary	H-1081
44	Durata Clinical Site	Budapest		Hungary
45	Durata Study Site	Debrecen		Hungary	H-4043
46	Durata Clinical Site	Kaposvar		Hungary	H-7400
47	Durata Clinical SIte	Pecs		Hungary	H-7624
48	Durata Clinical Site	Szeged		Hungary	H-6720
49	Durata Study Site	Veszprem		Hungary	H-8200
50	Durata Clinical Site	Haifa		Israel	31906
51	Durata Study Site	Jerusalem		Israel	91120
52	Durata Clinical Site	Kfar Saba		Israel	44281
53	Durata Study Site	Petach Tikva		Israel	49100
54	Durata Clinical Site	Petah-Tiqva		Israel	49100
55	Durata Clinical Site	Ramat-Gan		Israel	52621
56	Durata Study Site	Tel Aviv		Israel	64239
57	Durata Clinical Site	Jung Gu	Daegu	Korea, Republic of	700-721
58	Durata Clinical Site	Ansan		Korea, Republic of	425-707
59	Durata Study Site	Daejeon		Korea, Republic of	301721
60	Durata Study Site	Gwangju		Korea, Republic of	501-757
61	Durata Clinical Site	Incheon		Korea, Republic of	405-760
62	Durata Clinical Site	Kangwon-do		Korea, Republic of	220-71
63	Durata Study Site	Seoul		Korea, Republic of	133-791
64	Durata Clinical Site	Seoul		Korea, Republic of	134-701
65	Durata Study Site	Seoul		Korea, Republic of	134-701
66	Durata Study Site	Seoul		Korea, Republic of	135-710
67	Durata Clinical Site	Seoul		Korea, Republic of	136-705
68	Durata Study Site	Seoul		Korea, Republic of	138-736
69	Durata Clinical Site	Seoul		Korea, Republic of	152-703
70	Durata Clinical Site	Daugavpils		Latvia	LV-5417
71	Durata Clinical Site	Liepaja		Latvia	LV-3414
72	Durata Study Site	Rezekne		Latvia	LV-4600
73	Durata Study Site	Riga		Latvia	LV-1001
74	Durata Clinical Site	Riga		Latvia	LV-1002
75	Durata Clinical Site	Ventspils		Latvia	LV-3601
76	Durata Clinical Site	Kaunas		Lithuania	LT-45130
77	Durata Clinical Site	Kauno m. sav		Lithuania	LT-47144
78	Durata Clinical Site	Klaipėda		Lithuania	LT-76231
79	Durata Clinical Trial	Vilnius		Lithuania	LT-10207
80	Durata Clinical Site	Šiauliai		Lithuania	LT-76231
81	Durata Study Site	Bucharest		Romania	010713
82	Durata Clinical Site	Bucharest		Romania	010825
83	Durata Study Site	Bucharest		Romania	011461
84	Durata Clinical Trial	Bucharest		Romania	042122
85	Durata Study Site	Bucharest		Romania	75622
86	Durata Clinical Site	Burcharest		Romania	020125
87	Durata Study Site	Cluj-Napoca		Romania	400006
88	Durata Study Site	Constanta		Romania	900709
89	Durata Study Site	Targu Mures		Romania	540072
90	Durata Clinical Site	Timisoara		Romania	300736
91	Durata Clinical Site	Vsevolozhsk	Leningrad Region	Russian Federation	188640
92	Durata Study Site	Vsevolozhsk	Leningrad	Russian Federation	188864
93	Durata Study Site	Moscow		Russian Federation	111539
94	Durata Clinical Site	Moscow		Russian Federation	115280
95	Durata Study Site	Petrozavodsk		Russian Federation	18519
96	Durata Clinical Site	Smolensk		Russian Federation	214018
97	Durata Clinical Site	St. Petersburg		Russian Federation	198099
98	Durata Study Site	Tomsk		Russian Federation
99	Durata Clinical Site	Tver		Russian Federation	170036
100	Durata Clinical Site	Volgograd		Russian Federation	400138
101	Durata Clinical Site	Yaroslavl		Russian Federation	150003
102	Durata Clinical Site	Banska Bystrica		Slovakia	975 17
103	Durata Clinical Site	Levice		Slovakia	934 01
104	Durata Clinical Site	Nitra		Slovakia	950 01
105	Durata Clinical Site	Svidnik		Slovakia	089 01
106	Durata Study Site	KwaZulu	Durban	South Africa	4037
107	Durata Study Site	KwaZulu-Natal	Ladysmieth	South Africa	3370
108	Durata Study Site	Mpumalanga	Middleburg	South Africa	1055
109	Durata Study Site	Mpekweni	Paarl	South Africa	7646
110	Durata Study Site	Western Cape	Paarl	South Africa	7646
111	Durata Clinical Site	Gauteng	Pretoria	South Africa	0001
112	Durata Study Site	Gauteng	Soweto	South Africa	2013
113	Durata Study Site	Johannesburg		South Africa	1500
114	Durata Study Site	Port Elizabeth		South Africa	6014
115	Durata Study Site	Port Elizabeth		South Africa	6070
116	Durata Clinical Site	Pretoria		South Africa	0084
117	Durata Study Site	Thabazimbi		South Africa	0380
118	Durata Study Site	Tainan	Fukien	Taiwan	70403
119	Durata Study Site	Kaohsiung		Taiwan	813
120	Durata Study Site	Kaohsiung		Taiwan	ROC 807
121	Durata Clinical Site	Taichung City		Taiwan	40447
122	Durata Clinical Site	Taipai		Taiwan
123	Durata Study Site	Taipei		Taiwan	10002
124	Durata Study Site	Yung Kang City		Taiwan	71044
125	Durata Study Site	Cherkasy		Ukraine	18009
126	Durata Study Site	Dnipropetrovsk		Ukraine	49005
127	Durata Study Site	Donetsk		Ukraine	83099
128	Durata Clinical Site	Ivano-Frankivsk		Ukraine	76014
129	Durata Study Site	Ivano-Frankivsk		Ukraine	76014
130	Durata Study Site	Ivano-Frankivsk		Ukraine	76025
131	Durata Study Site	Kharkiv		Ukraine	61058
132	Durata Clinical Site	Kyiv		Ukraine	02666
133	Durata Study Site	Kyiv		Ukraine	02666
134	Durata Study Site	Lviv		Ukraine	79013
135	Durata Study Site	Lviv		Ukraine	79059
136	Durata Study Site	Uzhhorod		Ukraine	88000
137	Durata Study Site	Zaporizhia		Ukraine	69032

Sponsors and Collaborators

• Durata Therapeutics Inc., an affiliate of Allergan plc

Investigators

• Study Director: Michael Dunne, MD, Durata Therapeutics Inc., an affiliate of Allergan plc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Durata Therapeutics Inc., an affiliate of Allergan plc
• ClinicalTrials.gov Identifier: NCT01431339
• Other Study ID Numbers: DUR001-302
• First Posted: Sep 9, 2011
• Last Update Posted: Feb 12, 2014
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Cellulitis; Vancomycin; Linezolid; Dalbavancin

Study Results

Participant Flow

Arm/Group Title	Dalbavancin	Vancomycin With Possible Switch to Oral Linezolid
Arm/Group Description	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
Period Title: Overall Study
STARTED	371	368
Safety Population	368	367
COMPLETED	332	333
NOT COMPLETED	39	35

Baseline Characteristics

Arm/Group Title	Dalbavancin	Vancomycin With Possible Switch to Oral Linezolid	Total
Arm/Group Description	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	Total of all reporting groups
Overall Participants	371	368	739
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.1 (16.54)	51.4 (16.16)	50.2 (16.38)
Sex: Female, Male (Count of Participants)
Female	148 39.9%	167 45.4%	315 42.6%
Male	223 60.1%	201 54.6%	424 57.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.

Arm/Group Title	Dalbavancin	Vancomycin With Possible Switch to Oral Linezolid
Arm/Group Description	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
Measure Participants	371	368
Clinical Responder	285 76.8%	288 78.3%
Clinical Non-Responder	86 23.2%	80 21.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dalbavancin, Vancomycin With Possible Switch to Oral Linezolid
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Proportions
	Estimated Value	-1.5
	Confidence Interval	() 95%; -7.4 to 4.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Confidence intervals were adjusted for fever at baseline

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.

Arm/Group Title	Dalbavancin	Vancomycin With Possible Switch to Oral Linezolid
Arm/Group Description	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
Measure Participants	324	302
Clinical Succcess	303 81.7%	280 76.1%
Clinical Failure	21 5.7%	22 6%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.

Arm/Group Title	Dalbavancin	Vancomycin With Possible Switch to Oral Linezolid
Arm/Group Description	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
Measure Participants	371	368
Clinical Responder	325 87.6%	316 85.9%
Clinical Non-Responder	46 12.4%	52 14.1%

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.

Arm/Group Title	Dalbavancin	Vancomycin With Possible Switch to Oral Linezolid
Arm/Group Description	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
Measure Participants	294	272
Clinical Success	283 76.3%	257 69.8%
Clinical Failure	11 3%	15 4.1%

Adverse Events

Time Frame	Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected.
Adverse Event Reporting Description	Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Arm/Group Title	Dalbavancin		Vancomycin With Possible Switch to Oral Linezolid
Arm/Group Description	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
All Cause Mortality
	Dalbavancin		Vancomycin With Possible Switch to Oral Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dalbavancin		Vancomycin With Possible Switch to Oral Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/368 (3.3%)		14/367 (3.8%)
Cardiac disorders
Cardiac failure congestive	1/368 (0.3%)		0/367 (0%)
Cardiopulmonary failure	0/368 (0%)		1/367 (0.3%)
Gastrointestinal disorders
Inguinal hernia	1/368 (0.3%)		0/367 (0%)
Gastrointestinal disorder	0/368 (0%)		1/367 (0.3%)
Duodenal ulcer perforation	0/368 (0%)		1/367 (0.3%)
Peritonitis	0/368 (0%)		1/367 (0.3%)
General disorders
Systemic inflammatory response syndrome	0/368 (0%)		1/367 (0.3%)
Sudden death	0/368 (0%)		1/367 (0.3%)
Hepatobiliary disorders
Cholecystitis acute	0/368 (0%)		1/367 (0.3%)
Immune system disorders
Food allergy	1/368 (0.3%)		0/367 (0%)
Anaphylactoid reaction	1/368 (0.3%)		0/367 (0%)
Infections and infestations
Abscess	0/368 (0%)		1/367 (0.3%)
Cellulitis	3/368 (0.8%)		0/367 (0%)
Arthritis bacterial	1/368 (0.3%)		0/367 (0%)
Gangrene	0/368 (0%)		2/367 (0.5%)
Sepsis	1/368 (0.3%)		1/367 (0.3%)
Necrotising fasciitis	1/368 (0.3%)		0/367 (0%)
Bacterial sepsis	0/368 (0%)		1/367 (0.3%)
Appendicitis	0/368 (0%)		1/367 (0.3%)
Injury, poisoning and procedural complications
Rib fracture	1/368 (0.3%)		0/367 (0%)
Humerus fracture	1/368 (0.3%)		0/367 (0%)
Investigations
Blood glucose increased	0/368 (0%)		1/367 (0.3%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/368 (0%)		1/367 (0.3%)
Hypokalaemia	0/368 (0%)		1/367 (0.3%)
Renal and urinary disorders
Renal failure acute	0/368 (0%)		1/367 (0.3%)
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema	0/368 (0%)		1/367 (0.3%)
Pulmonary embolism	1/368 (0.3%)		0/367 (0%)
Skin and subcutaneous tissue disorders
Erythema	0/368 (0%)		1/367 (0.3%)
Vascular disorders
Deep vein thrombosis	0/368 (0%)		1/367 (0.3%)
Other (Not Including Serious) Adverse Events
	Dalbavancin		Vancomycin With Possible Switch to Oral Linezolid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/368 (7.9%)		28/367 (7.6%)
Gastrointestinal disorders
Nausea	15/368 (4.1%)		15/367 (4.1%)
Vomiting	8/368 (2.2%)		4/367 (1.1%)
Diarrhoea	4/368 (1.1%)		8/367 (2.2%)
Nervous system disorders
Headache	11/368 (3%)		9/367 (2.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI will provide Durata an opportunity to review any proposed publication or other type of disclosure at least 30 days before they are submitted. If any patent action is required to protect intellectual property rights, the Investigator agrees to delay the disclosure for a period not to exceed an additional 60 days. If the study is part of a multi-center study, the Investigator agrees that the first publication is to be a joint publication covering all centers.