None listed
Conditions
Interventions
moxifloxacin 400 mg iv, once daily, for at least 3 days, followed by moxifloxacin 400 mg po, once daily, for 7–21 days
Duration of treatment: A minimum of 7 days and a maximum of 21 days (for combined IV/PO treatment duration)
Group name:Group II Type of group
amoxicillin/clavulanate 1,000 mg/200 mg iv, three times
daily, for at least 3 days, followed by amoxicillin/clavulanate 500 mg/125 mg po, three times daily, for 7–21 days
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients >= 18 years of age were eligible for enrolment if they had a cSSSI at one site only, if it was anticipated that they required systemic antimicrobial therapy, and if they had had a sample culture taken within 24 h prior to being included in the study. Patients with pathogens showing in vitro resistance to the study drugs could be included based on the judgment of the investigator. In this study, the following cSSSI diagnoses were prospectively defined: diabetic foot infection, necrotizing fasciitis, post-surgical wound infection, complicated cellulitis, complicated erysipelas, major abscess of the skin, infection of traumatic lesion, and infected ischemic ulcer. Patients also had to have one of the following signs and symptoms – fever >0 38.0 °C axillary or >= 38.5 °C orally; leukocytosis (absolute white blood cell [WBC] count > 10,000 cells/ml) with neutrophilia (> 80% neutrophils), tachycardia (> 90 beats per minute), increased respiratory rate (> 20 breaths per minute), or elevated C-reactive protein (CRP) – plus two or more of the following signs and symptoms within 24 h preceding enrolment: local pain or tenderness, anesthesia or hypoesthesia of the affected area, swelling of the presumed affected area, purulent, serosanguinous, ‘dishwater’ or foul-smelling discharge, gas formation detected under the skin, and changes in the appearance of the involved area, such as discoloration of skin, presence of black necrotic areas, red-brown or hemorrhagic bullae, or skin color changes from red-blue to patches of bluegrey.
Exclusion criteria
Exclusion criteria: Patients with diagnoses of uncomplicated mild-to-moderate SSSIs and of secondary infected burns, atopic dermatitis, or eczema were excluded from the study. Women who were pregnant or nursing Patients with severe life-threatening diseases with a life expectancy 18% of the skin and soft tissue affected Suspected underlying osteomyelitis not related to diabetic foot infection Requirement for systemic concomitant antibacterial agents Failure to respond to previous antibacterial treatment only if previous treatment contained a fluoroquinolone, amoxicillin or a beta-lactam/beta-lactamase inhibitor combination Patients who had received systemic antibacterial treatment (po or parenteral) for > 24 h within the 24 h immediately prior to enrolment in the study were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical response at the TOC visit was defined as: cure (total resolution or marked improvement of all cSSSI signs and symptoms; no additional or alternative antimicrobial treatment necessary), failure (persistence orworsening of cSSSI signs and symptoms, expansion to the adjacent tissues or organs, or systemic skin-borne signs and/or symptoms of a generalized infection; more aggressive adjunctive treatment and a change, or a re-start of antimicrobial treatment necessary), or indeterminate (no evaluation possible because of unrecoverable data or any other fact). Measure:clinical response Timepoints:at test-of-cure (TOC; days 14–28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:The clinical response at Day 3 atter the beginning of treatment. Timepoints:Day 3 ; Outcome name:The incidence of sepsis in both treatment groups. The incidence of development of nosocomial infections in both treatment groups in relation with the length of hospitalization. The number of days of hospitalization in both treatment regimens. Major healthcare resources used in both treatment groups during the study period, from Day 1 after the beginning of treatment, to Days 14 to 28 after the end of the study treatment. Measure:incidence of sepsis incidence of development of nosocomial infections number of days of hospitalization Major healthcare resources used Timepoints:From Day 1 after the beginning of treatment, to Days 14 to 28 after the end of the study treatment. ; Outcome name:Aerobic and anaerobic cultures Measure:The bacteriological response al Day 3 after the beginning of treatment. Timepoints:Day 3 ; Outcome name:Aerobic and anaerobic cultures Measure:The bacteriological response at Days 14 to 28 after the end of treatment. Timepoints:Days 14 to 28 | — |
Countries
Argentina, Chile, Colombia, Germany, Hungary, Israel, Mexico, Peru, Philippines, South Africa, Spain, Taiwan
Outcome results
None listed