A Study for Patients With Complicated Skin and Skin Structure Infections (SIMPLIFI)
This study has been completed.
Sponsor:
Targanta Therapeutics Corporation
Information provided by:
Targanta Therapeutics Corporation
ClinicalTrials.gov Identifier:
NCT00514527
First received: August 8, 2007
Last updated: August 13, 2008
Last verified: August 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Staphylococcal Skin Infections Wounds and Injuries Abscess Cellulitis Streptococcal Infections |
Drug: oritavancin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI) |
Resource links provided by NLM:
Further study details as provided by Targanta Therapeutics Corporation:
Primary Outcome Measures:
- Clinical success at follow-up [ Time Frame: six months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate safety of dosing regimens. [ Time Frame: six months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 294 |
| Study Start Date: | August 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.
|
| Experimental: 2 |
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.
|
| Experimental: 3 |
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514527
Show 66 Study Locations
Show 66 Study LocationsSponsors and Collaborators
Targanta Therapeutics Corporation
Investigators
| Study Director: | Targanta Therapeutics | simplifi@covance.com |
More Information
No publications provided
| Responsible Party: | Targanta Therapeutics Corporation |
| ClinicalTrials.gov Identifier: | NCT00514527 History of Changes |
| Other Study ID Numbers: | TAR-ORI-SD001 |
| Study First Received: | August 8, 2007 |
| Last Updated: | August 13, 2008 |
| Health Authority: | United States: Food and Drug Administration Czech Republic: State Institute for Drug Control India: Indian Council of Medical Research Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Romania: National Medicines Agency Romania: State Institute for Drug Control Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health Australia: National Health and Medical Research Council Spain: Comité Ético de Investigación Clínica |
Additional relevant MeSH terms:
|
Abscess Cellulitis Skin Diseases, Infectious Staphylococcal Skin Infections Streptococcal Infections Wounds and Injuries Suppuration Infection |
Inflammation Pathologic Processes Connective Tissue Diseases Skin Diseases Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Skin Diseases, Bacterial |
ClinicalTrials.gov processed this record on October 17, 2012
