Trial · NCT01431339

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

NCT01431339, Phase 3, Completed, Durata Therapeutics Inc., an affiliate of Allergan plc; results first posted 2014-02-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections. Trials, record NCT01431339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01431339

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT number: NCT01431339
Status: Completed
Phases: Phase 3
Enrollment: 739 participants, actual
Lead sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Conditions: Abscess, Wound Infection, Surgical Site Infection, Cellulitis
Interventions: IV Dalbavancin, Vancomycin/Linezolid
First posted: 2011-09-09
Last updated: 2014-02-12
Results first posted: 2014-02-12

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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
Secondary	>= 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
Secondary	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

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Early Clinical Efficacy	After 48-72 hours of therapy	The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.	participants	NUMBER
SECONDARY	Clinical Status	End of Treatment Visit (Day 14-15)	Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.	participants	NUMBER
SECONDARY	>= 20% Reduction in Lesion Area	48-72 hours after the initiation of study therapy	The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.	participants	NUMBER
SECONDARY	Clinical Status	Follow-Up Visit (day 28)	Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.	participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Early Clinical Efficacy	Dalbavancin	Clinical Responder	285	participants
Early Clinical Efficacy	Vancomycin With Possible Switch to Oral Linezolid	Clinical Responder	288	participants
Early Clinical Efficacy	Dalbavancin	Clinical Non-Responder	86	participants
Early Clinical Efficacy	Vancomycin With Possible Switch to Oral Linezolid	Clinical Non-Responder	80	participants
Clinical Status	Dalbavancin	Clinical Succcess	303	participants
Clinical Status	Vancomycin With Possible Switch to Oral Linezolid	Clinical Succcess	280	participants
Clinical Status	Dalbavancin	Clinical Failure	21	participants
Clinical Status	Vancomycin With Possible Switch to Oral Linezolid	Clinical Failure	22	participants
>= 20% Reduction in Lesion Area	Dalbavancin	Clinical Responder	325	participants
>= 20% Reduction in Lesion Area	Vancomycin With Possible Switch to Oral Linezolid	Clinical Responder	316	participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dalbavancin	371
Overall Study	STARTED	Vancomycin With Possible Switch to Oral Linezolid	368
Overall Study	Safety Population	Dalbavancin	368
Overall Study	Safety Population	Vancomycin With Possible Switch to Oral Linezolid	367
Overall Study	COMPLETED	Dalbavancin	332
Overall Study	COMPLETED	Vancomycin With Possible Switch to Oral Linezolid	333
Overall Study	NOT COMPLETED	Dalbavancin	39
Overall Study	NOT COMPLETED	Vancomycin With Possible Switch to Oral Linezolid	35

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Dalbavancin	15	368
other	Nausea	Gastrointestinal disorders	Vancomycin With Possible Switch to Oral Linezolid	15	367
other	Headache	Nervous system disorders	Dalbavancin	11	368
other	Headache	Nervous system disorders	Vancomycin With Possible Switch to Oral Linezolid	9	367
other	Vomiting	Gastrointestinal disorders	Dalbavancin	8	368
other	Vomiting	Gastrointestinal disorders	Vancomycin With Possible Switch to Oral Linezolid	4	367
other	Diarrhoea	Gastrointestinal disorders	Dalbavancin	4	368
other	Diarrhoea	Gastrointestinal disorders	Vancomycin With Possible Switch to Oral Linezolid	8	367
serious	Systemic inflammatory response syndrome	General disorders	Dalbavancin	0	368
serious	Systemic inflammatory response syndrome	General disorders	Vancomycin With Possible Switch to Oral Linezolid	1	367

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dalbavancin
Total, all-cause mortality	Vancomycin With Possible Switch to Oral Linezolid
Total, other adverse events	Dalbavancin	29	368
Total, other adverse events	Vancomycin With Possible Switch to Oral Linezolid	28	367
Total, serious adverse events	Dalbavancin	12	368
Total, serious adverse events	Vancomycin With Possible Switch to Oral Linezolid	14	367

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24897082	DERIVED	PubMed
34905144	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Dalbavancin vs Vancomycin With Possible Switch to Oral Linezolid: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01431339

GET https://conductscience.org/api/trials/v1/NCT01431339/events?page=2

API reference For AI assistants