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

Use our guide to learn which trials are right for you!

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
?
mi
from
Buena Park, CA
Click here to add this to my saved trials
Channelview, Texas 77530
?
mi
from
Channelview, TX
Click here to add this to my saved trials
Deland, Florida 32770
?
mi
from
Deland, FL
Click here to add this to my saved trials
Franklin, Tennessee 37067
?
mi
from
Franklin, TN
Click here to add this to my saved trials
Indianapolis, Indiana
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
La Mesa, California 91942
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lincoln, Nebraska 68510
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Miami, Florida
?
mi
from
Miami, FL
Click here to add this to my saved trials
Modesto, California 95350
?
mi
from
Modesto, CA
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Seattle, Washington
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sofia, Sofia-Grad
?
mi
from
Sofia,
Click here to add this to my saved trials
Torrance, California 90503
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Washington, District of Columbia 20017
?
mi
from
Washington,
Click here to add this to my saved trials