None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with PPI-0903 600 mg IV q12 hours, infused for 1 hour for 7 to 21 days according to clinical response.
Group name:GROUP 2 Type of group
This group will be treated with standard therapy that will consist of Vancomycin 1g IV Q12 hours. The drug may be changed sensitivity to penicillin-resistant penicillins is demonstrated, to any of the following: Oxacillin, Nafcillin, Flucloxacillin, or Cloxacillin, each administered in a 2g IV dose for 30 minutes q6 hours. If Gram negative or polymicrobial infection is found, Aztreonam 1g IV may be added for 30 minutes q8 hours. This regimen will be administered for 7 to 21 days according to cli
Sponsors
CEREXA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women> 18 years of age 2. Complicated infection of the skin or structures of the skin. 3. Clinical findings: I. Local signs at the cSSSI site. II. Systemic signs 4. Requirements for treatment: I. The infection and / or condition of the patient would require, according to the standard of treatment, the initial hospitalization. II. The infection of the subject would require, according to the standard of treatment, the administration of IV antimicrobials.
Exclusion criteria
Exclusion criteria: 1. History of any type of hypersensitivity or allergic reaction to any B-lactam antibiotic. 2. History of any type of hypersensitivity or allergic reaction to any sulphite. 3. History of any type of hypersensitivity or allergic reaction to vancomycin or a history of red man syndrome. 4. Current or past history of epilepsy or convulsive disorder. 5. More than a single dose of an antibiotic that does not belong to the study. 6. Pre-existing Gram-positive infection with known or suspected resistance to vancomycin or Gram-negative infection with known or suspected resistance to aztreonam or ceftriaxone. 7. Furunculosis, carbunculosis or folliculitis. 8. Infection of the skin and structures of the skin: a) With known or suspected presence of anaerobic pathogens. b) With known or suspected presence of fungal, parasitic or viral pathogens. c) With a known or suspected presence of Pseudomonas aeruginosa as a contributing pathogen. d) Which comprises an ischemic ulcer due to PVD. e) That includes a decubitus ulcer. f) That comprises a diabetic foot ulcer. 9. Infections of the skin and structures of the skin with a high rate of healing after the surgical incision. 10. Infections of the skin and skin structures of the same type in separate and distinguishable anatomical sites. 11. Known or suspected infections related to the cSSSI, but present or originated in other sites or anatomical spaces. 12. Requirement for antibacterial or systemic antifungal therapy. 13. Requirement for concomitant treatment with valproic acid or probenecid. 14. Probenecid administration in the previous 3 days. 15. Requirement for concomitant treatment with Class Ia antiarrhythmic agents. 16. Infection or disorders that require systemic corticosteroids. 17. Impaired renal function. 18. Evidence of significant respiratory, hepatic or hematologic disease. 19. Evidence of immediate potentially fatal disease. 20. Evidence of significant heart disease. 21. History of nephrolithiasis. 22. Life expectancy of less than 3 months. 23. Women who are pregnant, who are breastfeeding, or if they have reproductive potential, do not use a clinically accepted method of birth control. 24. Participation in any study that involves the administration of an agent in research within the previous 30 days. 25. Previous participation in a study of PPI-0903. 26. Can not or is not willing to observe the specific procedures and restrictions of the study. 27. Has a condition that would compromise the patient´s safety or the quality of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Criteria for clinical cure, clinical failure or indeterminate response. Measure:Clinical response. Timepoints:8-14 days after the last treatment administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Criteria for clinical cure, clinical failure or indeterminate response. Infection site culture. Measure:Secondary efficacy: Clinical response per patient at the EOT visit. Microbiological response per patient at the OCD visit. Relapsed by patient in the LFU view. Timepoints:Clinical evaluation: Day 4 and on the last day of treatment, in addition to the 8-14 days after the last administration of the treatment. Microbiological evaluation: Day 1, 4, last day of treatment and 8-14 days after the last administration of the treatment. ; Outcome name:Evaluation of adverse events. Physical examination of the patient. Laboratory exams. 12-lead ECG.. Measure:Safety of the treatment. Timepoints:Evaluation of adverse events and physical examination: Days 1, 3, 4, last day of treatment and 8-14 days after the last administration of the treatment. Laboratory tests: Days 3, 4, last day of treatment and 8-14 days after the last treatment administration. ECG: Before treatment, day 3 and 8-14 days after the last treatment administration. | — |
Countries
Argentina, Chile, Peru, Russian Federation, South Africa, United States
Outcome results
None listed