Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:6/21/2018
Start Date:November 1, 2015
End Date:January 30, 2017

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A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-1

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).

Inclusion Criteria:

1. written informed consent;

2. ≥18 years of age;

3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

5. the presence of purulent or seropurulent drainage or at least three signs and symptoms
of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

1. severely impaired arterial blood supply such that amputation of the infected
anatomical site is likely;

2. infected diabetic foot ulcers;

3. infected decubitus ulcers;

4. necrotizing fasciitis or gangrene;

5. uncomplicated skin or skin structure infection;

6. infections associated with a prosthetic device;

7. suspected or confirmed osteomyelitis;

8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression
therapy.
We found this trial at
16
sites
Buena Park, California 90620
15
mi
from 91732
Buena Park, CA
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Channelview, Texas 77530
1371
mi
from 91732
Channelview, TX
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Deland, Florida 32770
2177
mi
from 91732
Deland, FL
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Franklin, Tennessee 37067
1765
mi
from 91732
Franklin, TN
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Indianapolis, Indiana
1792
mi
from 91732
Indianapolis, IN
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La Mesa, California 91942
106
mi
from 91732
La Mesa, CA
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Lincoln, Nebraska 68510
1258
mi
from 91732
Lincoln, NE
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Long Beach, California 90813
22
mi
from 91732
Long Beach, CA
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McAllen, Texas 78503
1297
mi
from 91732
McAllen, TX
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Miami, Florida
2322
mi
from 91732
Miami, FL
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Modesto, California 95350
299
mi
from 91732
Modesto, CA
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Oceanside, California 92056
73
mi
from 91732
Oceanside, CA
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Seattle, Washington
965
mi
from 91732
Seattle, WA
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Sofia, Sofia-Grad
6596
mi
from 91732
Sofia,
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Torrance, California 90503
25
mi
from 91732
Torrance, CA
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Washington, District of Columbia 20017
2283
mi
from 91732
Washington,
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