Staphylococcal Skin InfectionsPhase 2SIMPLIFINCT00514527
A Study for Patients With Complicated Skin and Skin Structure Infections
A Phase 2 study testing oritavancin in people with Staphylococcal Skin Infections and Wounds and Injuries, run by Targanta Therapeutics Corporation at 66 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Skin Infections, Wounds and Injuries, Abscess
- What is being tested?
- oritavancin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 66 sitesin 6 countries
- Study dates
- Aug 2007to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
66 sites in 6 countries.
66 sites in 6 countries
United States33 sites
Targanta Recruiting Site
Albany, New York, 12208-1901
Targanta Recruiting Site
Anaheim, California, 92804
Targanta Recruiting Site
Arlington, Texas, 76012
Targanta Recruiting Site
Atlantis, Florida, 33462
Targanta Recruiting Site
Baton Rouge, Louisiana, 70808
Targanta Recruiting Site
Buena Park, California, 90620
Targanta Recruiting Site
Chula Vista, California, 91911
Targanta Recruiting Site
Columbus, Georgia, 31405
Targanta Recruiting Site
Columbus, Ohio, 43215
Targanta Recruiting Site
Cumberland, Maryland, 21502
Targanta Recruiting Site
Detroit, Michigan, 48202
Targanta Recruiting Site
Hawaiian Gardens, California, 90716
Targanta Recruiting Site
Houston, Texas, 77005
Targanta Recruiting Site
Houston, Texas, 77055
Targanta Recruiting Site
Indianapolis, Indiana, 46280
Targanta Recruiting Site
Inverness, Florida, 34452
Targanta Recruiting Site
Jackson, Tennessee, 38301
Targanta Recruiting Site
Lafayette, Louisiana, 70503
Targanta Recruiting Site
Long Beach, California, 90813
Targanta Recruiting Site
Los Angeles, California, 90015
Targanta Recruiting Site
Marietta, Georgia, 30060
Targanta Recruiting Site
Miami, Florida, 33136
Targanta Recruiting Site
Minneapolis, Minnesota, 55422
Targanta Recruiting Site
Mobile, Alabama, 36617
Targanta Recruiting Site
New Orleans, Louisiana, 70112
Targanta Recruiting Site
Oceanside, California, 92056
Targanta Recruiting Site
Rolling Hills Estates, California, 90274
Targanta Recruiting Site
Salt Lake City, Utah, 84102
Targanta Recruiting Site
San Jose, California, 95124
Targanta Recruiting Site
Savannah, Georgia, 31405
Targanta Recruiting Site
Springfield, Illinois, 602701
Targanta Recruiting Site
Toledo, Ohio, 43608
Targanta Recruiting Site
Torrance, California, 90509
India10 sites
Targanta Recruiting Site
Ahmedabad, Gujarat, 380016
Targanta Recruiting Site
Bangalore, Karnataka, 560 002
Targanta Recruiting Site
Bangalore, Karnataka, 560 034
Targanta Recruiting Site
Bangalore, Karnataka, 560047
Targanta Recruiting Site
Hyderabaad, Andhra Pradesh, 500034
Targanta Recruiting Site
Kochi, Kerala, 682026
Targanta Recruiting Site
Lucknow, Uttar Pradesh, 226003
Targanta Recruiting Site
Mumbai, Maharashtra, 400 008
Targanta Recruiting Site
Pune, Maharashtra, 411004
Targanta Recruiting Site
Vadodara, Gujarat, 390 001
Ukraine9 sites
Targanta Recruiting Site
Ivano-Frankivsk, 07618
Targanta Recruiting Site
Ivano-Frankivsk, 76000
Targanta Recruiting Site
Kharkiv, 61001
Targanta Recruiting Site
Kiev, 02094
Targanta Recruiting Site
Kiev, 02125
Targanta Recruiting Site
Kiev, 03039
Targanta Recruiting Site
Odesa, 65025
Targanta Recruiting Site
Ternopil, 46001
Targanta Recruiting Site
Zaporizhzhya, 69032
Australia6 sites
Targanta Recruiting Site
Cairns, Queensland, 4870
Targanta Recruiting Site
East Ringwood, Victoria, 3135
Targanta Recruiting Site
Fremantle, 6160
Targanta Recruiting Site
Nambour, Queensland, 4560
Targanta Recruiting Site
Parkville, Victoria, 3050
Targanta Recruiting Site
Woolloongabba, Queensland, 4102
Italy6 sites
Targanta Recruiting Site
Catania, 95124
Targanta Recruiting Site
Mantua, 46100
Targanta Recruiting Site
Milan, 20122
Targanta Recruiting Site
Pisa, 56126
Targanta Recruiting Site
Savona, 17100
Targanta Recruiting Site
Siena, 53100
Romania2 sites
Targanta Recruiting Site
Bucharest, 50098
Targanta Recruiting Site
Craiova, 01100
About this study
Official title: Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
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.
- Conditions
- Staphylococcal Skin Infections, Wounds and Injuries, Abscess, Cellulitis, Streptococcal Infections
- Being tested
- oritavancin
- Medical subject headings
- Staphylococcal Skin Infections, Wounds and Injuries, Abscess, Cellulitis, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oritavancinDrug
Oritavancin as a single, infrequent or daily dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: oritavancin |
| 2 | Experimental | Not described Receives: Drug: oritavancin |
| 3 | Experimental | Not described Receives: Drug: oritavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at follow-up
Measured: six months
Secondary outcomes (1)
To evaluate safety of dosing regimens.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal Skin InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Targanta Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Targanta Therapeutics, Study director, simplifi@covance.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514527
- Sponsor's protocol ID
- TAR-ORI-SD001
- Acronym
- SIMPLIFI
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2007
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21537018
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
- ClinicalTrials.gov ID
- NCT00514527
- Acronym / sponsor ID
- SIMPLIFI / TAR-ORI-SD001
- Conditions
- Staphylococcal Skin Infections, Wounds and Injuries, Abscess, Cellulitis, Streptococcal Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Targanta Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: oritavancin |
| 2 | Experimental | Drug: oritavancin |
| 3 | Experimental | Drug: oritavancin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oritavancinOritavancin as a single, infrequent or daily dose. | Drug | 1, 2, 3 |
Primary outcome
Clinical success at follow-up
Time frame: six months
1 secondary outcome
To evaluate safety of dosing regimens.
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2008.
- Derived from this study: PubMed 21537018Dunbar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Targanta Therapeutics study director
simplifi@covance.com
66 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oritavancin in people with Staphylococcal Skin Infections and Wounds and Injuries, run by Targanta Therapeutics Corporation at 66 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, India, Ukraine, Australia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success at follow-up (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2008.