search
Back to results

A Study for Patients With Complicated Skin and Skin Structure Infections (SIMPLIFI)

Primary Purpose

Staphylococcal Skin Infections, Wounds and Injuries, Abscess

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
oritavancin
Sponsored by
Targanta Therapeutics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Skin Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Complicated skin and skin structure infection, presumed or proven to be caused by gram-positive pathogen(s).
  • Patients, ages 18 years and older, must not be below normal body weight or morbidly obese.
  • Female patients must not be pregnant at time of enrollment and must agree to a reliable method of birth control during the study and for 6 months following the last dose of study drug.

Exclusion Criteria:

Patients:

  • with a condition which would prevent performing protocol safety and efficacy assessments.
  • who have received antibiotics for more than 24 hours within the last 3 days.
  • with an infection involving deep tissues or unlikely to be caused by gram positive bacteria
  • who are nursing and will not stop nursing for at least 6 months
  • with a prior allergic reaction to glycopeptides (e.g. vancomycin)

  • with any of the following:

    1. toxic shock syndrome or toxic-like syndrome
    2. presumed or proven infection caused by Clostridium species
    3. bone infections
    4. ischemic or gangrenous ulcers or wounds
    5. infections caused only by gram-negative bacteria
    6. infection of an artificial joint that cannot be removed
    7. infection of the scrotum, perineum or perianal region
    8. infection of a severe burn wound
    9. severe ear infection involving bone and/or cartilage
    10. infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset

Sites / Locations

  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site
  • Targanta Recruiting Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Clinical success at follow-up

Secondary Outcome Measures

To evaluate safety of dosing regimens.

Full Information

First Posted
August 8, 2007
Last Updated
August 13, 2008
Sponsor
Targanta Therapeutics Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00514527
Brief Title
A Study for Patients With Complicated Skin and Skin Structure Infections
Acronym
SIMPLIFI
Official Title
Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Targanta Therapeutics Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed. The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory. SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infections, Wounds and Injuries, Abscess, Cellulitis, Streptococcal Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oritavancin
Intervention Description
Oritavancin as a single, infrequent or daily dose.
Primary Outcome Measure Information:
Title
Clinical success at follow-up
Time Frame
six months
Secondary Outcome Measure Information:
Title
To evaluate safety of dosing regimens.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Complicated skin and skin structure infection, presumed or proven to be caused by gram-positive pathogen(s). Patients, ages 18 years and older, must not be below normal body weight or morbidly obese. Female patients must not be pregnant at time of enrollment and must agree to a reliable method of birth control during the study and for 6 months following the last dose of study drug. Exclusion Criteria: Patients: with a condition which would prevent performing protocol safety and efficacy assessments. who have received antibiotics for more than 24 hours within the last 3 days. with an infection involving deep tissues or unlikely to be caused by gram positive bacteria who are nursing and will not stop nursing for at least 6 months with a prior allergic reaction to glycopeptides (e.g. vancomycin) with any of the following: toxic shock syndrome or toxic-like syndrome presumed or proven infection caused by Clostridium species bone infections ischemic or gangrenous ulcers or wounds infections caused only by gram-negative bacteria infection of an artificial joint that cannot be removed infection of the scrotum, perineum or perianal region infection of a severe burn wound severe ear infection involving bone and/or cartilage infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Targanta Therapeutics
Organizational Affiliation
simplifi@covance.com
Official's Role
Study Director
Facility Information:
Facility Name
Targanta Recruiting Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Targanta Recruiting Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Targanta Recruiting Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Targanta Recruiting Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Targanta Recruiting Site
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Targanta Recruiting Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Targanta Recruiting Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Targanta Recruiting Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Targanta Recruiting Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Targanta Recruiting Site
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Targanta Recruiting Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Targanta Recruiting Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Targanta Recruiting Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Targanta Recruiting Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Targanta Recruiting Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Targanta Recruiting Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Targanta Recruiting Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Targanta Recruiting Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
602701
Country
United States
Facility Name
Targanta Recruiting Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Targanta Recruiting Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Targanta Recruiting Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Targanta Recruiting Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Targanta Recruiting Site
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Targanta Recruiting Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Targanta Recruiting Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Targanta Recruiting Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208-1901
Country
United States
Facility Name
Targanta Recruiting Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Targanta Recruiting Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Targanta Recruiting Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Targanta Recruiting Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Targanta Recruiting Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Targanta Recruiting Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Targanta Recruiting Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Targanta Recruiting Site
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Targanta Recruiting Site
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Targanta Recruiting Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Targanta Recruiting Site
City
East Ringwood
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Targanta Recruiting Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Targanta Recruiting Site
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Targanta Recruiting Site
City
Hyderabaad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Targanta Recruiting Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Targanta Recruiting Site
City
Baroda
State/Province
Gujarat
ZIP/Postal Code
390 001
Country
India
Facility Name
Targanta Recruiting Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 002
Country
India
Facility Name
Targanta Recruiting Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Targanta Recruiting Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560047
Country
India
Facility Name
Targanta Recruiting Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682026
Country
India
Facility Name
Targanta Recruiting Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 008
Country
India
Facility Name
Targanta Recruiting Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Targanta Recruiting Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Targanta Recruiting Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Targanta Recruiting Site
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Targanta Recruiting Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Targanta Recruiting Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Targanta Recruiting Site
City
Savona
ZIP/Postal Code
17100
Country
Italy
Facility Name
Targanta Recruiting Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Targanta Recruiting Site
City
Bucharest
ZIP/Postal Code
50098
Country
Romania
Facility Name
Targanta Recruiting Site
City
Craiova
ZIP/Postal Code
01100
Country
Romania
Facility Name
Targanta Recruiting Site
City
Ivano-frankovsk
ZIP/Postal Code
07618
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Ivano-frankovsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Kharkov
ZIP/Postal Code
61001
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Kiev
ZIP/Postal Code
02094
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Kiev
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Kiev
ZIP/Postal Code
03039
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Facility Name
Targanta Recruiting Site
City
Zaporizhzhya
ZIP/Postal Code
69032
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
21537018
Citation
Dunbar LM, Milata J, McClure T, Wasilewski MM; SIMPLIFI Study Team. Comparison of the efficacy and safety of oritavancin front-loaded dosing regimens to daily dosing: an analysis of the SIMPLIFI trial. Antimicrob Agents Chemother. 2011 Jul;55(7):3476-84. doi: 10.1128/AAC.00029-11. Epub 2011 May 2.
Results Reference
derived

Learn more about this trial

A Study for Patients With Complicated Skin and Skin Structure Infections

We'll reach out to this number within 24 hrs