Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00514527