A Study for Patients With Complicated Skin and Skin Structure Infections
NCT ID: NCT00514527
Last Updated: 2008-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
294 participants
INTERVENTIONAL
2007-08-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
oritavancin
Oritavancin as a single, infrequent or daily dose.
2
oritavancin
Oritavancin as a single, infrequent or daily dose.
3
oritavancin
Oritavancin as a single, infrequent or daily dose.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
oritavancin
Oritavancin as a single, infrequent or daily dose.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Targanta Therapeutics Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Targanta Therapeutics Corporation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Targanta Recruiting Site
Mobile, Alabama, United States
Targanta Recruiting Site
Anaheim, California, United States
Targanta Recruiting Site
Buena Park, California, United States
Targanta Recruiting Site
Chula Vista, California, United States
Targanta Recruiting Site
Hawaiian Gardens, California, United States
Targanta Recruiting Site
Long Beach, California, United States
Targanta Recruiting Site
Los Angeles, California, United States
Targanta Recruiting Site
Oceanside, California, United States
Targanta Recruiting Site
Rolling Hills Estates, California, United States
Targanta Recruiting Site
San Jose, California, United States
Targanta Recruiting Site
Torrance, California, United States
Targanta Recruiting Site
Atlantis, Florida, United States
Targanta Recruiting Site
Inverness, Florida, United States
Targanta Recruiting Site
Miami, Florida, United States
Targanta Recruiting Site
Columbus, Georgia, United States
Targanta Recruiting Site
Marietta, Georgia, United States
Targanta Recruiting Site
Savannah, Georgia, United States
Targanta Recruiting Site
Springfield, Illinois, United States
Targanta Recruiting Site
Indianapolis, Indiana, United States
Targanta Recruiting Site
Baton Rouge, Louisiana, United States
Targanta Recruiting Site
Lafayette, Louisiana, United States
Targanta Recruiting Site
New Orleans, Louisiana, United States
Targanta Recruiting Site
Cumberland, Maryland, United States
Targanta Recruiting Site
Detroit, Michigan, United States
Targanta Recruiting Site
Minneapolis, Minnesota, United States
Targanta Recruiting Site
Albany, New York, United States
Targanta Recruiting Site
Columbus, Ohio, United States
Targanta Recruiting Site
Toledo, Ohio, United States
Targanta Recruiting Site
Jackson, Tennessee, United States
Targanta Recruiting Site
Arlington, Texas, United States
Targanta Recruiting Site
Houston, Texas, United States
Targanta Recruiting Site
Houston, Texas, United States
Targanta Recruiting Site
Salt Lake City, Utah, United States
Targanta Recruiting Site
Cairns, Queensland, Australia
Targanta Recruiting Site
Nambour, Queensland, Australia
Targanta Recruiting Site
Woolloongabba, Queensland, Australia
Targanta Recruiting Site
East Ringwood, Victoria, Australia
Targanta Recruiting Site
Parkville, Victoria, Australia
Targanta Recruiting Site
Fremantle, , Australia
Targanta Recruiting Site
Hyderabaad, Andhra Pradesh, India
Targanta Recruiting Site
Ahmedabad, Gujarat, India
Targanta Recruiting Site
Vadodara, Gujarat, India
Targanta Recruiting Site
Bangalore, Karnataka, India
Targanta Recruiting Site
Bangalore, Karnataka, India
Targanta Recruiting Site
Bangalore, Karnataka, India
Targanta Recruiting Site
Kochi, Kerala, India
Targanta Recruiting Site
Mumbai, Maharashtra, India
Targanta Recruiting Site
Pune, Maharashtra, India
Targanta Recruiting Site
Lucknow, Uttar Pradesh, India
Targanta Recruiting Site
Catania, , Italy
Targanta Recruiting Site
Mantova, , Italy
Targanta Recruiting Site
Milan, , Italy
Targanta Recruiting Site
Pisa, , Italy
Targanta Recruiting Site
Savona, , Italy
Targanta Recruiting Site
Siena, , Italy
Targanta Recruiting Site
Bucharest, , Romania
Targanta Recruiting Site
Craiova, , Romania
Targanta Recruiting Site
Ivano-Frankivsk, , Ukraine
Targanta Recruiting Site
Ivano-Frankivsk, , Ukraine
Targanta Recruiting Site
Kharkiv, , Ukraine
Targanta Recruiting Site
Kiev, , Ukraine
Targanta Recruiting Site
Kiev, , Ukraine
Targanta Recruiting Site
Kiev, , Ukraine
Targanta Recruiting Site
Odesa, , Ukraine
Targanta Recruiting Site
Ternopil, , Ukraine
Targanta Recruiting Site
Zaporizhzhya, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TAR-ORI-SD001
Identifier Type: -
Identifier Source: org_study_id