None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with: Ceftaroline, at a dose of 600 mg, in IV infusion for 60 minutes, followed by Aztreonam Placebo, in IV infusion for 60 minutes, IDB. This scheme will be administered for 5-14 days, depending on the clinical response.
Group name:GROUP 2 Type of group
This group will be treated with: Vancomycin, at a dose of 1 g, in IV infusion for 60 minutes, followed by Aztreonam, at a dose of 1 g in IV infusion for 60 minutes, IDB. This scheme will be administered for 5-14 days, depending on the clinical response.
Sponsors
I3 LATIN AMERICA PERU S.A., CEREXA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Eighteen (18) years of age or older. 2. Infection of the skin or structures of the skin (SSSI) that meets ANY of the following criteria: a) With deep soft tissue involvement or requiring significant surgical intervention. b) Cellulitis or abscess in the lower extremities that occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease (PVD). 3. Three or more of the following clinical signs: Drainage or purulent or seropurulent discharge, Erythema, Fluctuation, Heat or localized heat, Pain or sensitivity to palpation, Oral temperature above 38 ° C or hypothermia (<35 ° C), Leukocyte count greater than 10,000 / mm3, More than 10% of immature neutrophils. 4. The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, according to the standard of care. 5. It is anticipated that the infection of the subject will require at least 5 days of intravenous antimicrobial treatment 6. Women with reproductive potential must agree and commit to using highly effective contraceptive methods. 7. Written informed consent, good disposition, and ability to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. History of any type of hypersensitivity or allergic reaction to any B-lactam antimicrobial. 2. History of any type of hypersensitivity or allergic reaction to vancomycin or aztreonam. 3. Previous or current antecedents of epilepsy or convulsive disorder. 4. More than 24 hours of treatment with an antimicrobial for the treatment of the current cSSSI within 96 hours prior to randomization. 5. Failure of vancomycin or aztreonam as a treatment for the current cSSSI, or previous isolation of a microorganism with in vitro resistance to vancomycin or aztreonam 6. Uncomplicated SSSI. 7. Infection of skin and skin structures with ANY of the following characteristics: a) Known or suspected anaerobic pathogens. b) Known or suspected fungal, parasitic, or viral pathogens. c) Pseudomonas aeruginosa known or suspected as a contributing pathogen. d) That involves a decubitus ulcer. e) That involves a diabetic foot ulcer or an ulcer associated with EVP. f) That requires significant surgical intervention that can not be carried out within 48 hours after beginning the treatment with the drug. g) Cases of cellulitis with a consistent history with improvement or clinical stabilization. h) That involves a third degree burn or burn that covers more than 5% of the total body surface area. i) That implies an inflammatory disease of the underlying skin. j) That involves human or animal bites. k) That implies a rapid necrotizing process. l) That involves gangrene of any etiology. m) Complicated by the presence of prosthetic materials. n) That probably require amputation. 8. Known or suspected endocarditis, osteomyelitis, or septic arthritis. 9. Requirement for concomitant antimicrobial treatment. 10. Probenecid administration within 3 days. 11. Infections or conditions that require concomitant systemic corticosteroid therapy at a dose equivalent to or greater than 40 mg of prednisone per day. 12. Severely impaired renal function. 13. Evidence of significant hepatic, hematologic, or immunologic disease. 14. Evidence of illness that immediately threatens life. 15. Life expectancy of less than 3 months. 16. Pregnant or breastfeeding women. 17. Participation in any study that involves the administration of an agent in research within the previous 30 days. 18. Previous participation in a ceftaroline study. 19. Can not or is not willing to adhere to the specific procedures and restrictions of the study. 20. Any disorder that would compromise the safety of the subject or the quality of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical determination of total resolution of all signs and symptoms of cSSSI, or improvement to such an extent that no additional antimicrobial treatment is required. Measure:Index of clinical cure by subject in the visit of the Healing Test (TOC). Timepoints:8 to 15 days after the administration of the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1 and 2: Clinical determination of total resolution of all signs and symptoms of cSSSI, or improvement to such an extent that additional antimicrobial treatment is no longer required. Criterion 3: The Microbiological Response per Patient, based on crops, which may be Favorable (eradicated or allegedly eradicated) or unfavorable (persistence or presumed persistence). Criterion 4: The Microbiological Response by Pathogen, based on crops, which may be: eradication, presumed eradication, persistence, presumed persistence, and indeterminate Criterion 5: Relapse of symptoms or clinical failure. Criterion 6: Relapse in subjects that meet the favorable microbiological response criteria. Measure:Secondary efficacy: 1) Index of clinical cure by subject in the TOC visit in the population with Intended-to-treat modified (MITT) clinic (cMITT). 2) Index of clinical cure by subject in the EOT visit in the MITT, cMITT and Clinically evaluated (CE) populations. 3) Microbiological response by subject in the TOC visit. 4) Clinical and microbiological response by pathogen in the TOC visit. 5) Relapse by subject in the LFU visit in clinically cured subjects. 6) Reinfection or recurrence by subject in the LFU visit during the TOC visit in subjects with a favorable microbiological response. Timepoints:Criteria 1, 3 and 4: 8 to 15 days after the administration of the last dose. Criterion 2: EOT: Days 4 to 14. Criteria 5 and 6: 21 to 35 days after the last dose. ; Outcome name:Criterion 1: Clinical evaluation of any undesirable medical event experienced by a patient to whom the research product has been administered. Criterion 2: Evaluation of any EA that produces: a) Death. b) Threatening situation for life. c) Hospitalization or prolongation of current hospitalization. d) Persistent or significant disability. e) Congenital anomaly. f) Events that place the subject in a situation of risk that may require medical or su | — |
Countries
Argentina, Brazil, Chile, Germany, Mexico, Peru, Poland, Romania, Russian Federation, Ukraine, United States
Contacts
Public ContactElizabeth Rospigliosi
I3 LATIN AMERICA PERU S.A.
Outcome results
None listed