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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 iclaprim compared to 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 |
|---|---|---|
| ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. | ≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). | Baseline and 48-72 hours after first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|---|---|---|
| David Huang, MD, PhD | Motif BioSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California | Buena Park | California | 90620 | 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. | |
| 29281036 |
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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 | Mar 20, 2018 |
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| vancomycin | Drug | Active comparator |
|
|
| La Mesa |
| California |
| 91942 |
| United States |
| California | Long Beach | California | 90806 | United States |
| California | Modesto | California | 95350-449 | United States |
| California | Oceanside | California | 92056 | United States |
| California | Torrance | California | 90503 | United States |
| District of Columbia | Washington D.C. | District of Columbia | 20017 | United States |
| Florida | DeLand | Florida | 32770-0834 | United States |
| Florida | Miami | Florida | 33144 | United States |
| Indiana | Indianapolis | Indiana | 46260 | United States |
| Nebraska | Lincoln | Nebraska | 68510-2462 | United States |
| Tennessee | Franklin | Tennessee | 37067 | United States |
| Tennessee | Franklin | Tennessee | 37094 | United States |
| Texas | Channelview | Texas | 77530 | United States |
| Texas | McAllen | Texas | 78503 | United States |
| Washington | Seattle | Washington | 98195 | United States |
| Bulgaria | Sofia | Sofia-Grad | 1431 | Bulgaria |
| Bulgaria | Sofia | 1527 | Bulgaria |
| Chile | Temuco | 4781151 | Chile |
| Colombia | Barranquilla | 80020 | Colombia |
| Germany | Cologne | Northwest | 50937 | Germany |
| Germany | Dessau | 6847 | Germany |
| Germany | Mainz | 55131 | Germany |
| Germany | Münster | 48149 | Germany |
| Latvia | Daugavpils | LV-5417 | Latvia |
| Latvia | Liepāja | LV3414 | Latvia |
| Latvia | Rēzekne | 4600 | Latvia |
| Latvia | Riga | LV-1002 | Latvia |
| Latvia | Riga | LV-1038 | Latvia |
| Peru | Cerro de Pasco | LIM | 1 | Peru |
| Peru | Cusco | Peru |
| Peru | Ica | Peru |
| Peru | La Libertad | Peru |
| Peru | Lima | 01 | Peru |
| Peru | Lima | 29 | Peru |
| Peru | Lima | 31 | Peru |
| Peru | Piura | Peru |
| Peru | San Borja | Peru |
| Peru | San Juán de Miraflores | 29 | Peru |
| Poland | Bydgoszcz | 85-094 | Poland |
| Poland | Olsztyn | 10-229 | Poland |
| Poland | Warsaw | 00-909 | Poland |
| Poland | Wroclaw | 51-124 | Poland |
| Puerto Rico | Ponce | 780 | Puerto Rico |
| Puerto Rico | Rio Grande | 745 | Puerto Rico |
| Ukraine | Cherkasy | 18009 | Ukraine |
| Ukraine | Ivano-Frankivsk | 76014 | Ukraine |
| Ukraine | Ivano-Frankivsk | 7608 | Ukraine |
| Ukraine | Kharkiv | 6100 | Ukraine |
| Ukraine | Kharkiv | 61037 | Ukraine |
| Ukraine | Kiev | 3110 | Ukraine |
| Ukraine | Odesa | 65025 | Ukraine |
| Ukraine | Odesa | 65082 | Ukraine |
| Ukraine | Zaporizhzhya | 69000 | Ukraine |
| Ukraine | Zaporizhzhya | 69032 | Ukraine |
| Ukraine | Zaporizhzhya | 69065 | Ukraine |
| Derived |
| Huang DB, O'Riordan W, Overcash JS, Heller B, Amin F, File TM, Wilcox MH, Torres A, Dryden M, Holland TL, McLeroth P, Shukla R, Corey GR. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clin Infect Dis. 2018 Apr 3;66(8):1222-1229. doi: 10.1093/cid/cix987. |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat Population (all patients randomized)
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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 | 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 | ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. | ≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT). | all randomized patients (ITT). | Posted | Number | percentage of participants | Baseline and 48-72 hours after first dose of study drug |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Resolution or Near Resolution of Lesion at Test of Cure Visit | Resolution or near resolution of lesion at Test of Cure (TOC) visit | all randomized patients (ITT population) | Posted | Number | participants | 7 to14 days after the end of treatment |
|
|
1 year
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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 | 298 | 9 | 298 | 151 | 298 |
| EG001 | Vancomycin | vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator | 2 | 300 | 14 | 300 | 128 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAEs | 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 |
|---|---|---|---|---|---|
| Adverse effects | Product Issues | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Huang | Motif BioSciences | 936-577-5770 | david.huang@motifbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2017 | Mar 20, 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 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| 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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| Puerto Rico |
|
| United States |
|
| Ukraine |
|
| Bulgaria |
|
| Peru |
|
|