- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00077675
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)
January 14, 2019 updated by: Cumberland Pharmaceuticals
A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world.
This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
National City, California, United States, 91950
- Paradise Valley Hospital, 2400 E. 4th Street
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism
- major abscess requiring surgical incision and drainage
- infected burn (see exclusion criteria for important qualifications)
- deep/extensive cellulitis
- infected ulcer (see exclusion criteria for important qualifications)
- wound infection
- Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment
Exclusion Criteria:
- Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
- Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Telavancin
|
Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
Other Names:
|
ACTIVE_COMPARATOR: Standard of care for cSSSI
cSSSI - comlicated skin and skin structure infections
|
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Time Frame: 7 to 14 days following completion of antibiotic treatment
|
|
7 to 14 days following completion of antibiotic treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (ACTUAL)
September 1, 2004
Study Completion (ACTUAL)
September 1, 2004
Study Registration Dates
First Submitted
February 10, 2004
First Submitted That Met QC Criteria
February 12, 2004
First Posted (ESTIMATE)
February 13, 2004
Study Record Updates
Last Update Posted (ACTUAL)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I6424-202b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infections, Gram-positive Bacterial
-
Ministry of Health, RwandaUnknownDisease Due to Gram-positive BacteriaRwanda
-
Melinta Therapeutics, LLCRecruitingGram Positive Bacterial InfectionsUnited States
-
Cubist Pharmaceuticals LLCCompletedGram-positive Bacterial InfectionsUnited States
-
Cubist Pharmaceuticals LLCCompleted
-
Imperial College LondonHammersmith Hospitals NHS TrustCompletedStaphylococcal Infections | Gram-positive Bacterial InfectionsUnited Kingdom
-
NovartisNovartis VaccinesCompletedBacterial Infection | Streptococcal Infection | Gram-positive Bacterial InfectionBelgium, Canada
-
Cumberland PharmaceuticalsTerminatedGram-Positive Bacterial InfectionsUnited States
-
Universitaire Ziekenhuizen KU LeuvenCompletedGram-Positive Bacterial InfectionsBelgium
-
PfizerAventis PharmaceuticalsTerminatedGram-Positive Bacterial InfectionsUnited States
-
University of ZurichUnknownGram-Positive Bacterial InfectionsSwitzerland
Clinical Trials on Telavancin
-
Cumberland PharmaceuticalsCompletedComplicated Skin and Skin Structure Infections | Hospital Acquired Bacterial Pneumonia | Ventilator Associated Bacterial Pneumonia | Gram Positive InfectionUnited States
-
Aaron CookCumberland PharmaceuticalsRecruitingSubarachnoid Hemorrhage, AneurysmalUnited States
-
Joseph L. Kuti, PharmDCumberland Pharmaceuticals, Inc.Completed
-
Cumberland PharmaceuticalsCompletedKidney Diseases | End Stage Renal DiseaseUnited States
-
Hartford HospitalMelinta Therapeutics, LLCNot yet recruiting
-
M.D. Anderson Cancer CenterTheravance BiopharmaCompletedBacteremia | InfectionUnited States
-
University of Illinois at ChicagoTheravance BiopharmaCompleted
-
Cumberland PharmaceuticalsTerminatedGram-Positive Bacterial InfectionsUnited States
-
Cumberland PharmaceuticalsCompleted