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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 proved gram-positive bacterial skin or skin structure infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin with possible switch to oral linezolid | Active Comparator |
| |
| Dalbavancin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV 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 | After 48-72 hours of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 other therapy | End of Treatment Visit (Day 14-15) |
| >= 20% Reduction in Lesion Area |
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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 Clinical Site | Montgomery | Alabama | 36106 | United States | ||
| Durata Clinical 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 | IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 |
| FG001 | Vancomycin With Possible Switch to Oral Linezolid | 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 |
| 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 every 12 hours). Total duration of therapy is 10-14 days |
|
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 | 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 | Follow-Up Visit (day 28) |
| Anaheim |
| California |
| 92804 |
| United States |
| Durata Clinical Site | Buena Park | California | 90620 | United States |
| Durata Study Site | Chula Vista | California | 91911 | United States |
| Durata Clinical Site | Long Beach | California | 90813 | United States |
| Durata Study Site | Los Angeles | California | 90015 | United States |
| Durata Study Site | Norwalk | California | 90650 | United States |
| Durata Study Site | Oxnard | California | 93030 | United States |
| Durata Study SIte | San Diego | California | 92120 | United States |
| Durata Study Site | Stockton | California | 95204 | United States |
| Durata Clinical Site | Boyton Beach | Florida | 33435 | United States |
| Durata Clinical Site | Fort Meyers | Florida | 33966 | United States |
| Durata Clinical Site | Miami | Florida | 33015 | United States |
| Durata Study Site | Orlando | Florida | 32837 | United States |
| Durata Clinical Site | Saint Cloud | Florida | 34769 | United States |
| Durata Clinical Site | Augusta | Georgia | 30901 | United States |
| Durata Study Site | Columbus | Georgia | 31904 | United States |
| Durata Clinical Site | Chicago | Illinois | 60637 | United States |
| Durata Study Site | Baton Rouge | Louisiana | 70809 | United States |
| Durata Study Site | New Orleans | Louisiana | 70112 | United States |
| Durata Study Site | Shreveport | Louisiana | 71101 | United States |
| Durata Study Site | Zachary | Louisiana | 70791 | United States |
| Durata Study Site | Las Vegas | Nevada | 89109 | United States |
| Durata Study Site | Springfield | Ohio | 45502 | United States |
| Durata Study Site | Philadelphia | Pennsylvania | 19103 | United States |
| Durata Study Site | Austin | Texas | 78701 | United States |
| Durata Clinical Site | Austin | Texas | 78752 | United States |
| Durata Clinical Site | Houston | Texas | 77055 | United States |
| Durata Study Site | Richmond | Texas | 77469 | United States |
| Durata Study Site | Middleton | Wisconsin | 53562 | United States |
| Durata Study Site | Pleven | 5800 | Bulgaria |
| Durata Study Site | Plovdiv | 4000 | Bulgaria |
| Durata Study Site | Sevlievo | 5400 | Bulgaria |
| Durata Study Site | Sofia | 1000 | Bulgaria |
| Durata Study Site | Sofia | 1407 | Bulgaria |
| Durata Study Site | Sofia | 1431 | Bulgaria |
| Durata Study Site | Sofia | 1606 | Bulgaria |
| Durata Study Site | Kohtla-Järve | 30322 | Estonia |
| Durata Clinical Site | Kohtla-Järve | Estonia |
| Durata Clinical Site | Tallinn | 10136 | Estonia |
| Durata Clinical Site | Tallinn | 13419 | Estonia |
| Durata Study Site | Tartu | 51014 | Estonia |
| Durata Study Site | Budapest | H-1081 | Hungary |
| Durata Clinical Site | Budapest | Hungary |
| Durata Study Site | Debrecen | H-4043 | Hungary |
| Durata Clinical Site | Kaposvár | H-7400 | Hungary |
| Durata Clinical SIte | Pécs | H-7624 | Hungary |
| Durata Clinical Site | Szeged | H-6720 | Hungary |
| Durata Study Site | Veszprém | H-8200 | Hungary |
| Durata Clinical Site | Haifa | 31906 | Israel |
| Durata Study Site | Jerusalem | 91120 | Israel |
| Durata Clinical Site | Kfar Saba | 44281 | Israel |
| Durata Clinical Site | Petah Tikva | 49100 | Israel |
| Durata Study Site | Petah Tikva | 49100 | Israel |
| Durata Clinical Site | Ramat Gan | 52621 | Israel |
| Durata Study Site | Tel Aviv | 64239 | Israel |
| Durata Clinical Site | Daugavpils | LV-5417 | Latvia |
| Durata Clinical Site | Liepāja | LV-3414 | Latvia |
| Durata Study Site | Rēzekne | LV-4600 | Latvia |
| Durata Study Site | Riga | LV-1001 | Latvia |
| Durata Clinical Site | Riga | LV-1002 | Latvia |
| Durata Clinical Site | Ventspils | LV-3601 | Latvia |
| Durata Clinical Site | Kaunas | LT-45130 | Lithuania |
| Durata Clinical Site | Kauno M. Sav | LT-47144 | Lithuania |
| Durata Clinical Site | Klaipėda | LT-76231 | Lithuania |
| Durata Clinical Site | Šiauliai | LT-76231 | Lithuania |
| Durata Clinical Trial | Vilnius | LT-10207 | Lithuania |
| Durata Study Site | Bucharest | 010713 | Romania |
| Durata Clinical Site | Bucharest | 010825 | Romania |
| Durata Study Site | Bucharest | 011461 | Romania |
| Durata Clinical Trial | Bucharest | 042122 | Romania |
| Durata Study Site | Bucharest | 75622 | Romania |
| Durata Clinical Site | Burcharest | 020125 | Romania |
| Durata Study Site | Cluj-Napoca | 400006 | Romania |
| Durata Study Site | Constanța | 900709 | Romania |
| Durata Study Site | Târgu Mureş | 540072 | Romania |
| Durata Clinical Site | Timișoara | 300736 | Romania |
| Durata Clinical Site | Vsevolozhsk | Leningradskaya Oblast' | 188640 | Russia |
| Durata Study Site | Vsevolozhsk | Leningradskaya Oblast' | 188864 | Russia |
| Durata Study Site | Moscow | 111539 | Russia |
| Durata Clinical Site | Moscow | 115280 | Russia |
| Durata Study Site | Petrozavodsk | 18519 | Russia |
| Durata Clinical Site | Saint Petersburg | 198099 | Russia |
| Durata Clinical Site | Smolensk | 214018 | Russia |
| Durata Study Site | Tomsk | Russia |
| Durata Clinical Site | Tver' | 170036 | Russia |
| Durata Clinical Site | Volgograd | 400138 | Russia |
| Durata Clinical Site | Yaroslavl | 150003 | Russia |
| Durata Clinical Site | Banská Bystrica | 975 17 | Slovakia |
| Durata Clinical Site | Levice | 934 01 | Slovakia |
| Durata Clinical Site | Nitra | 950 01 | Slovakia |
| Durata Clinical Site | Svidník | 089 01 | Slovakia |
| Durata Study Site | KwaZulu | Durban | 4037 | South Africa |
| Durata Study Site | KwaZulu-Natal | Ladysmieth | 3370 | South Africa |
| Durata Study Site | Mpumalanga | Middleburg | 1055 | South Africa |
| Durata Study Site | Mpekweni | Paarl | 7646 | South Africa |
| Durata Study Site | Western Cape | Paarl | 7646 | South Africa |
| Durata Clinical Site | Gauteng | Pretoria | 0001 | South Africa |
| Durata Study Site | Gauteng | Soweto | 2013 | South Africa |
| Durata Study Site | Johannesburg | 1500 | South Africa |
| Durata Study Site | Port Elizabeth | 6014 | South Africa |
| Durata Study Site | Port Elizabeth | 6070 | South Africa |
| Durata Clinical Site | Pretoria | 0084 | South Africa |
| Durata Study Site | Thabazimbi | 0380 | South Africa |
| Durata Clinical Site | Jung Gu | Daegu | 700-721 | South Korea |
| Durata Clinical Site | Ansan | 425-707 | South Korea |
| Durata Study Site | Daejeon | 301721 | South Korea |
| Durata Study Site | Gwangju | 501-757 | South Korea |
| Durata Clinical Site | Incheon | 405-760 | South Korea |
| Durata Clinical Site | Kangwon-do | 220-71 | South Korea |
| Durata Study Site | Seoul | 133-791 | South Korea |
| Durata Clinical Site | Seoul | 134-701 | South Korea |
| Durata Study Site | Seoul | 134-701 | South Korea |
| Durata Study Site | Seoul | 135-710 | South Korea |
| Durata Clinical Site | Seoul | 136-705 | South Korea |
| Durata Study Site | Seoul | 138-736 | South Korea |
| Durata Clinical Site | Seoul | 152-703 | South Korea |
| Durata Study Site | Tainan | Fukien | 70403 | Taiwan |
| Durata Study Site | Kaohsiung City | 813 | Taiwan |
| Durata Study Site | Kaohsiung City | ROC 807 | Taiwan |
| Durata Clinical Site | Taichung | 40447 | Taiwan |
| Durata Clinical Site | Taipai | Taiwan |
| Durata Study Site | Taipei | 10002 | Taiwan |
| Durata Study Site | Yung Kang City | 71044 | Taiwan |
| Durata Study Site | Cherkasy | 18009 | Ukraine |
| Durata Study Site | Dnipropetrovsk | 49005 | Ukraine |
| Durata Study Site | Donetsk | 83099 | Ukraine |
| Durata Clinical Site | Ivano-Frankivsk | 76014 | Ukraine |
| Durata Study Site | Ivano-Frankivsk | 76014 | Ukraine |
| Durata Study Site | Ivano-Frankivsk | 76025 | Ukraine |
| Durata Study Site | Kharkiv | 61058 | Ukraine |
| Durata Clinical Site | Kyiv | 02666 | Ukraine |
| Durata Study Site | Kyiv | 02666 | Ukraine |
| Durata Study Site | Lviv | 79013 | Ukraine |
| Durata Study Site | Lviv | 79059 | Ukraine |
| Durata Study Site | Uzhhorod | 88000 | Ukraine |
| Durata Study Site | Zaporizhia | 69032 | Ukraine |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalbavancin | IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 |
| BG001 | Vancomycin With Possible Switch to Oral Linezolid | 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 |
| 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 | After 48-72 hours of 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 other therapy | 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 | >= 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 the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy | 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 | IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 | 12 | 368 | 29 | 368 | ||
| EG001 | Vancomycin With Possible Switch to Oral Linezolid | 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 | 14 | 367 | 28 | 367 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systemic inflammatory response syndrome | General disorders | MedDRA 14.0 |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
| ||
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Blood glucose increased | Investigations | MedDRA 14.0 |
| ||
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 |
| ||
| Abscess | Infections and infestations | MedDRA 14.0 |
| ||
| Cellulitis | Infections and infestations | MedDRA 14.0 |
| ||
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.0 |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 14.0 |
| ||
| Food allergy | Immune system disorders | MedDRA 14.0 |
| ||
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 |
| ||
| Arthritis bacterial | Infections and infestations | MedDRA 14.0 |
| ||
| Sudden death | General disorders | MedDRA 14.0 |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 |
| ||
| Gangrene | Infections and infestations | MedDRA 14.0 |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
| ||
| Sepsis | Infections and infestations | MedDRA 14.0 |
| ||
| Cardiopulmonary failure | Cardiac disorders | MedDRA 14.0 |
| ||
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 |
| ||
| Necrotising fasciitis | Infections and infestations | MedDRA 14.0 |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
| ||
| Anaphylactoid reaction | Immune system disorders | MedDRA 14.0 |
| ||
| Bacterial sepsis | Infections and infestations | MedDRA 14.0 |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 |
| ||
| Appendicitis | Infections and infestations | MedDRA 14.0 |
| ||
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Peritonitis | Gastrointestinal disorders | MedDRA 14.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Headache | Nervous system disorders | MedDRA 14.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 |
| ||
| Diarrhoea | Gastrointestinal 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@duratatx.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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
|
|
|