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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00514527
Other study ID # TAR-ORI-SD001
Secondary ID
Status Completed
Phase Phase 2
First received August 8, 2007
Last updated August 13, 2008
Start date August 2007
Est. completion date May 2008

Study information

Verified date August 2008
Source Targanta Therapeutics Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCzech Republic: State Institute for Drug ControlIndia: Indian Council of Medical ResearchItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthRomania: National Medicines AgencyRomania: State Institute for Drug ControlUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthAustralia: National Health and Medical Research CouncilSpain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 294
Est. completion date May 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
oritavancin
Oritavancin as a single, infrequent or daily dose.

Locations

Country Name City State
Australia Targanta Recruiting Site Cairns Queensland
Australia Targanta Recruiting Site East Ringwood Victoria
Australia Targanta Recruiting Site Fremantle
Australia Targanta Recruiting Site Nambour Queensland
Australia Targanta Recruiting Site Parkville Victoria
Australia Targanta Recruiting Site Woolloongabba Queensland
India Targanta Recruiting Site Ahmedabad Gujarat
India Targanta Recruiting Site Bangalore Karnataka
India Targanta Recruiting Site Bangalore Karnataka
India Targanta Recruiting Site Bangalore Karnataka
India Targanta Recruiting Site Baroda Gujarat
India Targanta Recruiting Site Hyderabaad Andhra Pradesh
India Targanta Recruiting Site Kochi Kerala
India Targanta Recruiting Site Lucknow Uttar Pradesh
India Targanta Recruiting Site Mumbai Maharashtra
India Targanta Recruiting Site Pune Maharashtra
Italy Targanta Recruiting Site Catania
Italy Targanta Recruiting Site Mantova
Italy Targanta Recruiting Site Milano
Italy Targanta Recruiting Site Pisa
Italy Targanta Recruiting Site Savona
Italy Targanta Recruiting Site Siena
Romania Targanta Recruiting Site Bucharest
Romania Targanta Recruiting Site Craiova
Ukraine Targanta Recruiting Site Ivano-frankovsk
Ukraine Targanta Recruiting Site Ivano-frankovsk
Ukraine Targanta Recruiting Site Kharkov
Ukraine Targanta Recruiting Site Kiev
Ukraine Targanta Recruiting Site Kiev
Ukraine Targanta Recruiting Site Kiev
Ukraine Targanta Recruiting Site Odessa
Ukraine Targanta Recruiting Site Ternopil
Ukraine Targanta Recruiting Site Zaporizhzhya
United States Targanta Recruiting Site Albany New York
United States Targanta Recruiting Site Anaheim California
United States Targanta Recruiting Site Arlington Texas
United States Targanta Recruiting Site Atlantis Florida
United States Targanta Recruiting Site Baton Rouge Louisiana
United States Targanta Recruiting Site Buena Park California
United States Targanta Recruiting Site Chula Vista California
United States Targanta Recruiting Site Columbus Georgia
United States Targanta Recruiting Site Columbus Ohio
United States Targanta Recruiting Site Cumberland Maryland
United States Targanta Recruiting Site Detroit Michigan
United States Targanta Recruiting Site Hawaiian Gardens California
United States Targanta Recruiting Site Houston Texas
United States Targanta Recruiting Site Houston Texas
United States Targanta Recruiting Site Indianapolis Indiana
United States Targanta Recruiting Site Inverness Florida
United States Targanta Recruiting Site Jackson Tennessee
United States Targanta Recruiting Site Lafayette Louisiana
United States Targanta Recruiting Site Long Beach California
United States Targanta Recruiting Site Los Angeles California
United States Targanta Recruiting Site Marietta Georgia
United States Targanta Recruiting Site Miami Florida
United States Targanta Recruiting Site Minneapolis Minnesota
United States Targanta Recruiting Site Mobile Alabama
United States Targanta Recruiting Site New Orleans Louisiana
United States Targanta Recruiting Site Oceanside California
United States Targanta Recruiting Site Rolling Hills Estates California
United States Targanta Recruiting Site Salt Lake City Utah
United States Targanta Recruiting Site San Jose California
United States Targanta Recruiting Site Savannah Georgia
United States Targanta Recruiting Site Springfield Illinois
United States Targanta Recruiting Site Toledo Ohio
United States Targanta Recruiting Site Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Targanta Therapeutics Corporation

Countries where clinical trial is conducted

United States,  Australia,  India,  Italy,  Romania,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical success at follow-up six months No
Secondary To evaluate safety of dosing regimens. six months No
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