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This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.
This is a multicenter, randomized, double-blind study of the efficacy and safety of IV iclaprim compared to IV vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iclaprim | Experimental | iclaprim 80 mg intravenous every 12 hours |
|
| vancomycin | Active Comparator | vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iclaprim | Drug | Experimental treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline | ≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). | Baseline and 48 to 72 hours after first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit | Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit. | 7 to14 days after the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Noviello, MD | Motif Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California | Anaheim | California | 92804 | United States | ||
| California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29783024 | Derived | Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19. | |
| 29530858 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iclaprim | iclaprim 80 mg intravenous every 12 hours Iclaprim: Experimental treatment |
| FG001 | Vancomycin | vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance Vancomycin: Active comparator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2015 | Jun 14, 2018 |
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| Vancomycin | Drug | Active comparator |
|
|
| Buena Park |
| California |
| 90620 |
| United States |
| California | Chula Vista | California | 91911 | United States |
| California | La Palma | California | 90623 | United States |
| California | Long Beach | California | 90813 | United States |
| St. Mary Medical Center ER | Long Beach | California | 90813 | United States |
| Florida | Hollywood | Florida | 33021 | United States |
| Florida | Miami | Florida | 33130-2433 | United States |
| Florida | Miami | Florida | 33130 | United States |
| Georgia | Columbus | Georgia | 31904 | United States |
| Montana | Butte | Montana | 59701 | United States |
| Nevada | Las Vegas | Nevada | 89109 | United States |
| New Jersey | Somers Point | New Jersey | 08244 | United States |
| Ohio | Lima | Ohio | 45801 | United States |
| Tennessee | Smyrna | Tennessee | 37167-6826 | United States |
| Washington | Kennewick | Washington | 99336 | United States |
| Washington | Richland | Washington | 99352 | United States |
| Argentina | Buenos Aires | C1425DQK | Argentina |
| Argentina | Buenos Aires | C1430BKC | Argentina |
| Belgium | Brussels | 1000 | Belgium |
| Belgium | Brussels | 1070 | Belgium |
| Croatia | Slavonski Brod | 35000 | Croatia |
| Croatia | Zadar | 23000 | Croatia |
| Croatia | Zagreb | 10000 | Croatia |
| Czech Republic | Hradec Králové | 500 05 | Czechia |
| Czech Republic | Ostrava | 70852 | Czechia |
| Czech Republic | PÅ™Ãbram | 261 01 | Czechia |
| Czech Republic | Ústà nad Labem | 400 11 | Czechia |
| Estonia | Kohtla-Järve | 31025 | Estonia |
| Estonia | Tallinn | 13419 | Estonia |
| Estonia | Tallinn | 31419 | Estonia |
| Estonia | Tartu | 51014 | Estonia |
| Estonia | Võru | 65526 | Estonia |
| Hungary | Budapest | 1085 | Hungary |
| Hungary | Miskolc | 3529 | Hungary |
| Hungary | Szeged | 6720 | Hungary |
| Hungary | Székesfehérvár | 8000 | Hungary |
| Hungary | Veszprém | 8200 | Hungary |
| Portugal | Amadora | 2720-276 | Portugal |
| Portugal | Braga | 4710-243 | Portugal |
| Portugal | Porto | 4200-319 | Portugal |
| Portugal | Santarém | 2005-177 | Portugal |
| Portugal | Viana do Castelo | 4901-858 | Portugal |
| Romania | Arad | 310037 | Romania |
| Romania | Bucharest | 20475 | Romania |
| Romania | Bucharest | 41914 | Romania |
| Romania | Bucharest | 42122 | Romania |
| Romania | Bucharest | 50098 | Romania |
| Romania | Cluj-Napoca | 400162 | Romania |
| Romania | Craiova | 200642 | Romania |
| Romania | Timișoara | 300736 | Romania |
| Turkey | Aydin | 9100 | Turkey (Türkiye) |
| Turkey | Istanbul | 34098 | Turkey (Türkiye) |
| Turkey | Trabzon | 61080 | Turkey (Türkiye) |
| Derived |
| Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iclaprim | iclaprim 80 mg intravenous every 12 hours Iclaprim: Experimental treatment |
| BG001 | Vancomycin | vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance Vancomycin: Active comparator |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline | ≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 48 to 72 hours after first dose of study drug |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit | Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit. | Posted | Number | participants | 7 to14 days after the end of treatment |
|
|
1 month
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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 | Iclaprim | iclaprim 80 mg intravenous every 12 hours Iclaprim: Experimental treatment | 0 | 299 | 0 | 299 | 0 | 299 |
| EG001 | Vancomycin | vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance Vancomycin: Active comparator | 1 | 302 | 1 | 302 | 1 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Product Issues | Renal and urinary disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Noviello | Motif BioSciences | 908-432-7802 | stephanie.noviello@motifbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2017 | Jun 14, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C486448 | iclaprim |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Romania |
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| Turkey |
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| Belgium |
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| Hungary |
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| United States |
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| Czechia |
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| Portugal |
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| Estonia |
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| Croatia |
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| Mexico |
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