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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00514527




Registration number
NCT00514527
Ethics application status
Date submitted
8/08/2007
Date registered
10/08/2007
Date last updated
14/08/2008

Titles & IDs
Public title
A Study for Patients With Complicated Skin and Skin Structure Infections
Scientific title
Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
Secondary ID [1] 0 0
TAR-ORI-SD001
Universal Trial Number (UTN)
Trial acronym
SIMPLIFI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staphylococcal Skin Infections 0 0
Wounds and Injuries 0 0
Abscess 0 0
Cellulitis 0 0
Streptococcal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - oritavancin

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -


Treatment: Drugs: oritavancin
Oritavancin as a single, infrequent or daily dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical success at follow-up
Timepoint [1] 0 0
six months
Secondary outcome [1] 0 0
To evaluate safety of dosing regimens.
Timepoint [1] 0 0
six months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
294
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Targanta Recruiting Site - Cairns
Recruitment hospital [2] 0 0
Targanta Recruiting Site - Nambour
Recruitment hospital [3] 0 0
Targanta Recruiting Site - Woolloongabba
Recruitment hospital [4] 0 0
Targanta Recruiting Site - East Ringwood
Recruitment hospital [5] 0 0
Targanta Recruiting Site - Parkville
Recruitment hospital [6] 0 0
Targanta Recruiting Site - Fremantle
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4560 - Nambour
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
India
State/province [16] 0 0
Andhra Pradesh
Country [17] 0 0
India
State/province [17] 0 0
Gujarat
Country [18] 0 0
India
State/province [18] 0 0
Karnataka
Country [19] 0 0
India
State/province [19] 0 0
Kerala
Country [20] 0 0
India
State/province [20] 0 0
Maharashtra
Country [21] 0 0
India
State/province [21] 0 0
Uttar Pradesh
Country [22] 0 0
Italy
State/province [22] 0 0
Catania
Country [23] 0 0
Italy
State/province [23] 0 0
Mantova
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Pisa
Country [26] 0 0
Italy
State/province [26] 0 0
Savona
Country [27] 0 0
Italy
State/province [27] 0 0
Siena
Country [28] 0 0
Romania
State/province [28] 0 0
Bucharest
Country [29] 0 0
Romania
State/province [29] 0 0
Craiova
Country [30] 0 0
Ukraine
State/province [30] 0 0
Ivano-frankovsk
Country [31] 0 0
Ukraine
State/province [31] 0 0
Kharkov
Country [32] 0 0
Ukraine
State/province [32] 0 0
Kiev
Country [33] 0 0
Ukraine
State/province [33] 0 0
Odessa
Country [34] 0 0
Ukraine
State/province [34] 0 0
Ternopil
Country [35] 0 0
Ukraine
State/province [35] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Targanta Therapeutics Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00514527
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Targanta Therapeutics
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00514527