Wound Infection Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.
This was a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with ABSSSI suspected or proven to be caused by gram-positive pathogens. Approximately 960 participants were to be randomized at 100 centers globally. In addition, this study characterized the pharmacokinetics (PK) and PK/pharmacodynamics (PD) properties of a single 1200-mg IV dose of oritavancin and evaluated the potential health economic benefits offered by this dosing strategy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02905955 -
Vacuumtherapy After Venous Hybrid Procedures
|
Phase 4 | |
| Not yet recruiting |
NCT02868372 -
Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
|
N/A | |
| Enrolling by invitation |
NCT02559453 -
Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds
|
N/A | |
| Completed |
NCT02744144 -
Wound Bacterial Microbiota and Their Antibiotic Resistance
|
N/A | |
| Active, not recruiting |
NCT01939145 -
Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
|
Phase 4 | |
| Completed |
NCT00998907 -
PDS*Plus and Wound Infections After Laparotomy
|
N/A | |
| Completed |
NCT01141335 -
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
|
Phase 4 | |
| Completed |
NCT00576745 -
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
|
Phase 1 | |
| Terminated |
NCT00654641 -
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
|
N/A | |
| Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
| Recruiting |
NCT00150852 -
Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.
|
Phase 2 | |
| Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
| Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
| Active, not recruiting |
NCT04584957 -
Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)
|
N/A | |
| Recruiting |
NCT03960970 -
Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries
|
Phase 2 | |
| Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
| Completed |
NCT02018094 -
The Amputation Surgical Site Infection Trial (ASSIT)
|
Phase 4 | |
| Terminated |
NCT03269968 -
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
|
N/A | |
| Enrolling by invitation |
NCT02945761 -
High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound
|
N/A | |
| Not yet recruiting |
NCT02882360 -
Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum
|
Phase 4 |