cSSSIs MedDRA version: 9.1 Level: LLT Classification code 10040872 Term: Skin infection
Conditions
Interventions
Trade Name: AVALOX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Moxifloxacin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Sponsors
BAYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: men or women of age > or equal to 18 years with diagnosis of cSSSIs that requires: - hospitalization, - initial parenteral therapy for at least 48 h, - complicated by at least one of the following criteria: involvement of deep soft tissues, requirement for a significant surgical intervention, association with a significant underlying disease that may complicate response to treatment, presence of SIRS. Duration of infectione 1 cm from wound edge, edema, pain or tenderness to palpation, swelling or induration, fever, CRP>20 mg/L. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women who are pregnant or lactating the following SSSI: necrotizing fasciitis including Fournier gangrene, ecthyma gangrenosus, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis , burn wound infection, secondary infections of a chronic a skin disease (es atopic dermatitis), infection of prosthetic materials, infections where a surgical procedure alone is definitive therapy, follicolitis, foruncolosis, carbuncolosis, simple abscessis and superficial cellulitis. Known hypersensitivity to quinolones and/or any type of betalattam antibiotic drugs or any of the eccipients. History of cholestatic jaundice/hepatic disfunction associated with amoxicillin/clavulanic acid Severe life-threatening disease with a life expectancy or equal 2 weeks with known con immunosuppressant therapy, any other difetto congenital or acquired immune defect or immunosuppression severe hepatic insufficiency (Child-Pugh C) or transaminases increase > 5 fold ULN renal impairment with baseline creatinine clearance 24 h in the previous 7 days. Infection to be due to a MRSA, MRSE, VRE as the single isolated pathogen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the efficacy and safety of two sequential (IV/PO) treatment regimens for the treatment of adult subjects with cSSSis: Moxifloxacin 400 mh IV every 24 h followed by moxifloxacin 400 mg PO every 24 h versus amoxicillin/clavulanate 2000/200 mg IVevery 8 h followed by amoxicillin/clavulanate 875/125 mg PO every 8 h;Secondary Objective: ;Primary end point(s): Response at the Test of Cure (TOC) at follow-up visit after 14-21 days after last dose. | — |
Countries
Italy
Outcome results
None listed