A Phase 3 interventional study of Dalbavancin and Vancomycin / Linezolid in Abscess, Wound Infection and Surgical Site Infection, sponsored by Durata Therapeutics Inc., an affiliate of Allergan plc. Completed at 92 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-01-31.
Sponsored by Durata Therapeutics Inc., an affiliate of Allergan plc · Phase 3, Interventional, and Treatment
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 573 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Durata Therapeutics Inc., an affiliate of Allergan plc is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients presenting with any of the following:
Drug: Dalbavancin
Drug: Vancomycin / Linezolid
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
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
Time frame: 48-72 hours after the initiation of study 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
Time frame: 48-72 hours after the initiation of study therapy
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 non-study antibiotics
Time frame: End of Treatment Visit (Day 14-15)
Clinical Status
Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics
Time frame: Follow-Up Visit (day 28)
| Milestone | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| Started | 288 | 285 |
| Safety population | 284 | 284 |
| Completed | 261 | 257 |
| Not completed | 27 | 28 |
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
| participants | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| Clinical Responder | 240 | 233 |
| Clinical Non-Responder | 48 | 52 |
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size
| participants | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| Clinical Responder | 259 | 259 |
| Clinical Non-Responder | 29 | 26 |
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 non-study antibiotics
| participants | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| Clinical Success | 214 | 222 |
| Clinical Failure | 32 | 21 |
Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics
| participants | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| Clinical Success | 212 | 220 |
| Clinical Failure | 14 | 9 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dalbavancin | — | 5/284 (1.8%) | 36/284 (12.7%) |
| Vancomycin +/- Oral Linezolid | — | 12/284 (4.2%) | 54/284 (19%) |
| Event | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| Arthritis bacterialInfections and infestations | 1/284 | 0/284 |
| BacteraemiaInfections and infestations | 1/284 | 0/284 |
| Embolic pneumoniaInfections and infestations | 1/284 | 0/284 |
| Abscess limbInfections and infestations | 0/284 | 1/284 |
| CellulitisInfections and infestations | 0/284 | 1/284 |
| Diabetic foot infectionInfections and infestations | 0/284 | 1/284 |
| Rectal abscessInfections and infestations | 0/284 | 1/284 |
| Atrial fibrillationCardiac disorders | 1/284 | 0/284 |
| Cardiac failureCardiac disorders | 0/284 | 1/284 |
| Cardiac failure acuteCardiac disorders | 0/284 | 1/284 |
| Event | Dalbavancin | Vancomycin +/- Oral Linezolid |
|---|---|---|
| HeadacheNervous system disorders | 14/284 | 14/284 |
| NauseaGastrointestinal disorders | 12/284 | 13/284 |
| DiarrhoeaGastrointestinal disorders | 4/284 | 11/284 |
| PruritusSkin and subcutaneous tissue disorders | 1/284 | 11/284 |
| HypertensionVascular disorders | 7/284 | 7/284 |
| RashSkin and subcutaneous tissue disorders | 6/284 | 6/284 |
| VomitingGastrointestinal disorders | 3/284 | 6/284 |
| AstheniaGeneral disorders | 1/284 | 6/284 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/284 | 6/284 |
| Age, Continuous(years) | Dalbavancin | Vancomycin +/- Oral Linezolid | Total |
|---|---|---|---|
| Mean | 48.8 ± 15.3 | 48.9 ± 15.08 | 48.9 ± 15.18 |
| Sex: Female, Male(Participants) | Dalbavancin | Vancomycin +/- Oral Linezolid | Total |
|---|---|---|---|
| Female | 118 | 112 | 230 |
| Male | 170 | 173 | 343 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Durata Therapeutics Inc., an affiliate of Allergan plc