Prospective, randomized, non-blind, comparative with parallel groups, multicenter and multinational phase IH clinical study of the efficacy and safety of moxifloxacin 400 mg od sequential therapy versus amoxicillin/clavulanate 1 g IV tid followed by amoxicillin/clavulanate 625 mg PO tid for the treatment of complicated skin and skin structure infections during a 21-day period (Study 10279)

Not Applicable

• Conditions: -L089 Local infection of skin and subcutaneous tissue, unspecified; Local infection of skin and subcutaneous tissue, unspecified; L089

• Registration Number: PER-008-01
• Lead Sponsor: BAYER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-03-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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 < 2 months
End-stage liver cirrhosis (Child–Pugh C)
Severe renal impairment requiring dialysis
Septic shock
Patients receiving chronic immunosuppressant treatment
Neutropenia (neutrophils absolute count <= 1,000 cells/ml)
AIDS stage 1 or 2 (CD4+ absolute count < 200 cells/ll)
HIV-seropositive individuals receiving highly activated antiretroviral treatment.
Patients with known congenital or sporadic syndromes of QTc prolongation or taking concomitant medication reported to increase the QTc
Hypersensitivity to fluoroquinolones, and beta-lactams or those a history of tendinopathy with quinolones
SSSI secondary to prosthetic materials
> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified