AbscessPhase 3NCT01339091
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study testing Dalbavancin and Vancomycin / Linezolid in people with Abscess and Wound Infection, run by Durata Therapeutics Inc., an affiliate of Allergan plc at 91 sites in 8 countries.
Trial 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 proven gram-positive bacterial skin or skin structure infection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abscess, Wound Infection, Surgical Site Infection
- What is being tested?
- Dalbavancin and Vancomycin / Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 573 participants
- Where
- 91 sitesin 8 countries
- Study dates
- Mar 2011to Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
91 sites in 8 countries.
91 sites in 8 countries
United States55 sites
Durata Study Site
Anaheim, California, 92804
Durata Study Site
Azusa, California, 91702
Durata Study Site
Baton Rouge, Louisiana, 70808
Durata Study Site
Bellflower, California, 90706
Durata Study Site
Buena Park, California, 90620
Durata Study Site
Buffalo, New York, 14215
Durata Study Site
Carmel, California, 46032
Durata Study Site
Chula Vista, California, 92911
Durata Study Site
Columbus, Georgia, 31904
Durata Study Site
Columbus, Ohio, 43215
Durata Study Site
Covina, California, 91723
Durata Study Site
Detroit, Michigan, 48202
Durata Study Site
Fountain Valley, California, 92708
Durata Study Site
Houston, Texas, 77030
Durata Study Site
Houston, Texas, 77036
Durata Study Site
Idaho Falls, Idaho, 83404
Durata Study Site
La Mesa, California, 91942
Durata Study Site
Lafayette, Louisiana, 70503
Durata Study Site
Lake Success, New York, 11042
Durata Study Site
Las Vegas, Nevada, 89109
Durata Study Site
Lima, Ohio, 45801
Durata Study Site
Long Beach, California, 90813
Durata Study Site
Los Alamitos, California, 90720
Durata Study Site
Los Angeles, California, 90015
Durata Study Site
Madison, Wisconsin, 53717
Durata Study Site
Miami, Florida, 33144
Durata Study Site
Miami, Florida, 33155
Durata Study Site
Middleton, Wisconsin, 53562
Durata Study Site
Minneapolis, Minnesota, 55422
Durata Study Site
Moline, Illinois, 61265
Durata Study Site
New Hyde Park, New York, 11040
Durata Clinical Site
New Orleans, Louisiana, 70112
Durata Study Site
Oceanside, California, 92056
Durata Study Site
Opelousas, Louisiana, 70570
Durata Study Site
Orlando, Florida, 32837
Durata Study Site
Palm Desert, California, 92211
Durata Study Site
Pasadena, California, 91105
Durata Study Site
Pittsburgh, Pennsylvania, 15213
Durata Study Site
Pocatello, Idaho, 83202
Durata Study Site
Rock Island, Illinois, 31201
Durata Study Site
Sacramento, California, 95817
Durata Study Site
Saint Cloud, Florida, 34769
Durata Study Site
San Diego, California, 92120
Durata Study Site
Santa Ana, California, 92701
Durata Study Site
Savannah, Georgia, 31406
Durata Study Site
Somers Point, New Jersey, 08244
Durata Study Site
Staten Island, New York, 10305
Durata Study Site
Sylmar, California, 91342
Durata Study Site
Tampa, Florida, 33613
Durata Study Site
The Bronx, New York, 10467
Durata Study Site
Toledo, Ohio, 43608
Durata Study Site
Torrance, California, 90509
Durata Study Site
Upland, California, 91786
Durata Study Site
Whittier, California, 90602
Durata Study Site
Winston-Salem, North Carolina, 27103
Russia15 sites
Durata Study Site
Kharkiv, Ukraine, 61037
Durata Study Site
Kyiv City, Ukraine, 02125
Durata Study Site
Moscow, 111020
Durata Clinical Site
Moscow, 111539
Durata Study Site
Moscow, 129327
Durata Study Site
Perm, 614036
Durata Study Site
Saint Petersburg, 191104
Durata Study Site
Saint Petersburg, 192242
Durata Study Site
Saint Petersburg, 194354
Durata Study Site
Saint Petersburg, 198099
Durata Clinical Site
Saint Petersburg, 94354
Durata Study Site
Saratov, 410053
Durata Study Site
Smolensk, 214018
Durata Study Site
Tomsk, 634064
Durata Study Site
Yekaterinburg, 620095
Ukraine8 sites
Durata Study Site
Cherkasy, 18009
Durata Study Site
Ivano-Frankivsk, 76018
Durata Study Site
Kharkiv, 61037
Durata Study Site
Kyiv, 02125
Durata Study Site
Kyiv, 03110
Durata Study Site
Uzhhorod, 88018
Durata Study Site
Zaporizhzhya, 69032
Durata Study Site
Zhytomyr, 10002
Croatia4 sites
Durata Study Site
Dubrovnik, 2000
Durata Clinical Site
Slavonski Brod, 35000
Durata Study Site
Zagreb, 10000
Durata Study Site
Zagreb, 1000
Poland4 sites
Durata Study Site
Krakow, 31-501
Durata Study Site
Legionowo, 05-120
Durata Study Site
Warsaw, 03-401
Durata Study Site
Wroclaw, 51-124
Canada2 sites
Durata Study Site
Trois-Rivières, Quebec, G9A 1Y1
Durata Study Site
Winnipeg, Manitoba, R3E 0J9
Germany2 sites
Durata Study Site
Bochum, 44791
Durata Study Site
Münster, 48149
About this study
Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regiment (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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.
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Being tested
- Dalbavancin, Vancomycin / Linezolid
- Medical subject headings
- Abscess, Wound Infection, Surgical Wound Infection, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Vancomycin / LinezolidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Experimental | Not described Receives: Drug: Dalbavancin |
| Vancomycin with possible switch to oral linezolid | Active comparator | Not described Receives: Drug: Vancomycin / Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48-72 hours after the initiation of study therapy
Secondary outcomes (3)
>= 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
Measured: 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
Measured: 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
Measured: Follow-Up Visit (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dunne, MD, Study director, Durata Therapeutics Inc., an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339091
- Sponsor's protocol ID
- DUR001-301
- Status last verified
- Dec 2013
- First submitted
- 18 Apr 2011
- Last updated
- 31 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34905144Boucher 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.
PubMed 24897082
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regiment (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT01339091
- Acronym / sponsor ID
- DUR001-301
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Posted 25 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | Experimental | Drug: Dalbavancin |
| Vancomycin with possible switch to oral linezolid | Active comparator | Drug: Vancomycin / Linezolid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DalbavancinIV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 | Drug | Dalbavancin |
| Vancomycin / LinezolidIV 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. | Drug | Vancomycin with possible switch to oral linezolid |
Primary outcome
Early Clinical Efficacy
Time frame: 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 and temperature
3 secondary outcomes
>= 20% Reduction in Lesion Area
Time frame: 48-72 hours after the initiation of study therapy
Clinical Status
Time frame: End of Treatment Visit (Day 14-15)
Clinical Status
Time frame: Follow-Up Visit (day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34905144Gonzalez 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.
- Derived from this study: PubMed 24897082Boucher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dunne, MD study director
Durata Therapeutics Inc., an affiliate of Allergan plc
91 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalbavancin and Vancomycin / Linezolid in people with Abscess and Wound Infection, run by Durata Therapeutics Inc., an affiliate of Allergan plc at 91 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Russia, Ukraine, Croatia, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Clinical Efficacy (time frame: 48-72 hours after the initiation of study therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.