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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalbavancin | Experimental |
| |
| Vancomycin with possible switch to oral linezolid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalbavancin | Drug | IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48-72 hours after the initiation of study therapy |
| Measure | Description | Time Frame |
|---|---|---|
| >= 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 | 48-72 hours after the initiation of study therapy |
| Clinical Status |
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Inclusion Criteria:
Exclusion Criteria:
Patients presenting with any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Dunne, MD | Durata Therapeutics Inc., an affiliate of Allergan plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durata Study Site | Anaheim | California | 92804 | United States | ||
| Durata Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34905144 | Derived | 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. | |
| 24897082 | Derived | Boucher 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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| ID | Title | Description |
|---|---|---|
| FG000 | Dalbavancin | Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 |
| FG001 | Vancomycin +/- Oral Linezolid | Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vancomycin / Linezolid |
| Drug |
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. |
|
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 |
| 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 | Follow-Up Visit (day 28) |
| Azusa |
| California |
| 91702 |
| United States |
| Durata Study Site | Bellflower | California | 90706 | United States |
| Durata Study Site | Buena Park | California | 90620 | United States |
| Durata Study Site | Carmel | California | 46032 | United States |
| Durata Study Site | Chula Vista | California | 92911 | United States |
| Durata Study Site | Covina | California | 91723 | United States |
| Durata Study Site | Fountain Valley | California | 92708 | United States |
| Durata Study Site | La Mesa | California | 91942 | United States |
| Durata Study Site | Long Beach | California | 90813 | United States |
| Durata Study Site | Los Alamitos | California | 90720 | United States |
| Durata Study Site | Los Angeles | California | 90015 | United States |
| Durata Study Site | Oceanside | California | 92056 | United States |
| Durata Study Site | Palm Desert | California | 92211 | United States |
| Durata Study Site | Pasadena | California | 91105 | United States |
| Durata Study Site | Sacramento | California | 95817 | United States |
| Durata Study Site | San Diego | California | 92120 | United States |
| Durata Study Site | Santa Ana | California | 92701 | United States |
| Durata Study Site | Sylmar | California | 91342 | United States |
| Durata Study Site | Torrance | California | 90509 | United States |
| Durata Study Site | Upland | California | 91786 | United States |
| Durata Study Site | Whittier | California | 90602 | United States |
| Durata Study Site | Miami | Florida | 33144 | United States |
| Durata Study Site | Miami | Florida | 33155 | United States |
| Durata Study Site | Orlando | Florida | 32837 | United States |
| Durata Study Site | Saint Cloud | Florida | 34769 | United States |
| Durata Study Site | Tampa | Florida | 33613 | United States |
| Durata Study Site | Columbus | Georgia | 31904 | United States |
| Durata Study Site | Savannah | Georgia | 31406 | United States |
| Durata Study Site | Idaho Falls | Idaho | 83404 | United States |
| Durata Study Site | Pocatello | Idaho | 83202 | United States |
| Durata Study Site | Moline | Illinois | 61265 | United States |
| Durata Study Site | Rock Island | Illinois | 31201 | United States |
| Durata Study Site | Baton Rouge | Louisiana | 70808 | United States |
| Durata Study Site | Lafayette | Louisiana | 70503 | United States |
| Durata Clinical Site | New Orleans | Louisiana | 70112 | United States |
| Durata Study Site | Opelousas | Louisiana | 70570 | United States |
| Durata Study Site | Detroit | Michigan | 48202 | United States |
| Durata Study Site | Minneapolis | Minnesota | 55422 | United States |
| Durata Study Site | Las Vegas | Nevada | 89109 | United States |
| Durata Study Site | Somers Point | New Jersey | 08244 | United States |
| Durata Study Site | Buffalo | New York | 14215 | United States |
| Durata Study Site | Lake Success | New York | 11042 | United States |
| Durata Study Site | New Hyde Park | New York | 11040 | United States |
| Durata Study Site | Staten Island | New York | 10305 | United States |
| Durata Study Site | The Bronx | New York | 10467 | United States |
| Durata Study Site | Winston-Salem | North Carolina | 27103 | United States |
| Durata Study Site | Columbus | Ohio | 43215 | United States |
| Durata Study Site | Lima | Ohio | 45801 | United States |
| Durata Study Site | Toledo | Ohio | 43608 | United States |
| Durata Study Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Durata Study Site | Houston | Texas | 77030 | United States |
| Durata Study Site | Houston | Texas | 77036 | United States |
| Durata Study Site | Madison | Wisconsin | 53717 | United States |
| Durata Study Site | Middleton | Wisconsin | 53562 | United States |
| Durata Study Site | Winnipeg | Manitoba | R3E 0J9 | Canada |
| Durata Study Site | Trois-Rivières | Quebec | G9A 1Y1 | Canada |
| Durata Study Site | Dubrovnik | 2000 | Croatia |
| Durata Clinical Site | Slavonski Brod | 35000 | Croatia |
| Durata Study Site | Zagreb | 10000 | Croatia |
| Durata Study Site | Zagreb | 1000 | Croatia |
| Durata Clinical Site | Tbilisi | Georgia |
| Durata Study Site | Bochum | 44791 | Germany |
| Durata Study Site | Münster | 48149 | Germany |
| Durata Study Site | Krakow | 31-501 | Poland |
| Durata Study Site | Legionowo | 05-120 | Poland |
| Durata Study Site | Warsaw | 03-401 | Poland |
| Durata Study Site | Wroclaw | 51-124 | Poland |
| Durata Study Site | Kharkiv | Ukraine | 61037 | Russia |
| Durata Study Site | Kyiv City | Ukraine | 02125 | Russia |
| Durata Study Site | Moscow | 111020 | Russia |
| Durata Clinical Site | Moscow | 111539 | Russia |
| Durata Study Site | Moscow | 129327 | Russia |
| Durata Study Site | Perm | 614036 | Russia |
| Durata Study Site | Saint Petersburg | 191104 | Russia |
| Durata Study Site | Saint Petersburg | 192242 | Russia |
| Durata Study Site | Saint Petersburg | 194354 | Russia |
| Durata Study Site | Saint Petersburg | 198099 | Russia |
| Durata Clinical Site | Saint Petersburg | 94354 | Russia |
| Durata Study Site | Saratov | 410053 | Russia |
| Durata Study Site | Smolensk | 214018 | Russia |
| Durata Study Site | Tomsk | 634064 | Russia |
| Durata Study Site | Yekaterinburg | 620095 | Russia |
| Durata Study Site | Cherkasy | 18009 | Ukraine |
| Durata Study Site | Ivano-Frankivsk | 76018 | Ukraine |
| Durata Study Site | Kharkiv | 61037 | Ukraine |
| Durata Study Site | Kyiv | 02125 | Ukraine |
| Durata Study Site | Kyiv | 03110 | Ukraine |
| Durata Study Site | Uzhhorod | 88018 | Ukraine |
| Durata Study Site | Zaporizhzhya | 69032 | Ukraine |
| Durata Study Site | Zhytomyr | 10002 | Ukraine |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalbavancin | Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 |
| BG001 | Vancomycin +/- Oral Linezolid | Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug. | Posted | Number | participants | 48-72 hours after the initiation of study therapy |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | >= 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 | The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug. | Posted | Number | participants | 48-72 hours after the initiation of study therapy |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data. | Posted | Number | participants | End of Treatment Visit (Day 14-15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data. | Posted | Number | participants | Follow-Up Visit (day 28) |
|
|
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 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalbavancin | Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 | 5 | 284 | 36 | 284 | ||
| EG001 | Vancomycin +/- Oral Linezolid | Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days. | 12 | 284 | 54 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis bacterial | Infections and infestations | MedDRA 14.0 |
| ||
| Bacteraemia | Infections and infestations | MedDRA 14.0 |
| ||
| Embolic pneumonia | Infections and infestations | MedDRA 14.0 |
| ||
| Abscess limb | Infections and infestations | MedDRA 14.0 |
| ||
| Cellulitis | Infections and infestations | MedDRA 14.0 |
| ||
| Diabetic foot infection | Infections and infestations | MedDRA 14.0 |
| ||
| Rectal abscess | Infections and infestations | MedDRA 14.0 |
| ||
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 |
| ||
| Cardiac failure | Cardiac disorders | MedDRA 14.0 |
| ||
| Cardiac failure acute | Cardiac disorders | MedDRA 14.0 |
| ||
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 |
| ||
| Cardiopulmonary failure | Cardiac disorders | MedDRA 14.0 |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 14.0 |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.0 |
| ||
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 14.0 |
| ||
| Nephropathy toxic | Renal and urinary disorders | MedDRA 14.0 |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Hypertension | Vascular disorders | MedDRA 14.0 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Asthenia | General disorders | MedDRA 14.0 |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Zelasky | Durata Therapeutics | 203-871-4616 | mzelasky@duratatherapeutics.com |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D014946 | Wound Infection |
| D013530 | Surgical Wound Infection |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D012874 | Skin Diseases, Infectious |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
| D014640 | Vancomycin |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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|