Health Condition 1: null- Acute Bacterial Skin and Skin Structure Infection
Conditions
Interventions
Intervention1: Single-Dose IV Oritavancin Diphosphate
: Intravenous oritavancin single 1200 mg iv dose and IV placebo will be administered for a minimum of 7 days up to a maximum of 10 days.
Control I
Sponsors
The Medicines Company
PPD Pharmaceutical Development I Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects may be included in the study if they meet all of the following inclusion criteria: 1. Males or females more than or equal to 18 years old 2. Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 7 days of IV therapy 3. An ABSSSI includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess 4. ABSSSI must present with at least 2 signs and symptoms 5. Able to give informed consent and willing to comply with all required study procedures Note: As per the Indian Regulatory (DCGI) Approval for the study, patients aged more than or equal to 18 years and less than or equal to 65 years should be included in the study.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization: 1. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days - The causative Gram-positive pathogen(s)isolated from the ABSSSI site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or - Documented failure to previous ABSSSI antibiotic therapy is available. Documentation of treatment failure must be recorded - Patient received a single dose of a short- acting antibacterial therapy three or more days before randomization 2. Infections associated with, or in close proximity to, a prosthetic device 3. Severe sepsis or refractory shock 4. Known or suspected bacteremia at time of screening 5. ABSSSI due to or associated with any of the following: - Infections suspected or documented to be caused by Gram-negative pathogens -- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens - Diabetic foot infections - Concomitant infection at another site not including a secondary ABSSSI lesion - Infected burns - A primary infection secondary to a pre-existing skin disease with associated inflammatory changes - Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease - Any evolving necrotizing process gangrene or infection suspected or proven to be caused by Clostridium species - Infections known to be caused by a Gram-positive organism with a vancomycin MIC 2 ìg/mL or clinically failing prior therapy with glycopeptides - Catheter site infections 6. Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria 7. Currently receiving chronic systemic immunosuppressive therapy 8. AIDS with CD4 count 200 cells/mm3 9. Neutropenia 10. Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI 11. Women who are pregnant or nursing 12. History of immune-related hypersensitivity reaction to glycopeptides 13. Patients that require anticoagulant monitoring with an aPTT 14. Contraindication to vancomycin 15. Patients unwilling to forego blood and/or blood product donation 16. Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study 17. Investigational device present, or removed 30 days before enrollment, or presence of device-related infection 18. Patients unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study 19. Severe hepatic disease 20. Presence of hyperuricemia 21. Unwilling to refrain from chronic use of any medication with antipyretic properties Note: As per the Indian Regulatory (DCGI) Approval for the study, patients aged iess than 18 years and patients aged more than 65 years should be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cessation of spread or reduction in size of baseline lesion, absence of fever, and no rescue antibiotic medication at ECE (48 to 72 hours)Timepoint: 48 to 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure determined by the investigator at End Of Therapy, Day 10 and Post Therapy Evaluation visitsTimepoint: 7 to 14 days after end of therapy;Clinical response cessation of spread or reduction in size of baseline lesion, absence of fever & no rescue antibiotic medication & clinical cure & microbiological response within the Clinical Evaluable population & Microbiologically Evaluable population meeting SIRS criteria at screening.Timepoint: Start of study drug through 7 to 14 days after end of therapy;Pharmacokinetics of oritavancin including area under the plasma concentration-time curve (AUC), half-life (t1/2), clearance (CL), Cmax, and steady state volume of distribution (Vss)Timepoint: Day 1 through Day 24;Safety of oritavancin assessed according to vital signs, laboratory abnormalities, ECG, all-cause mortality and the incidence of adverse events (AEs) and SAEsTimepoint: 60 Days from Start of Therapy;The clinical cure determined by the investigator, overall, and by pathogen, at the EOT visit, Day 10, and at the PTE visitTimepoint: 7 to 14 days after end of therapy;The microbiological relapse (or recurrence) at the PTE visitTimepoint: 7 to 14 days after end of therapy;The microbiological response, overall and by pathogen, at the EOT visit, at Day 10, and at the PTE visitTimepoint: 7 to 14 days after end of therapy | — |
Countries
Argentina, Brazil, Canada, Chile, Colombia, France, Germany, India, Israel, Mexico, Peru, Poland, Republic of Korea, Romania, Russian Federation, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactArun Sundriyal
The Medicines Company
Outcome results
None listed