''A prospective, randomized, open label, active comparator, multicenter, national trial to compare the efficacy and safety of sequential IV/PO moxifloxacin 400 mg once daily versus IV amoxicillin/clavulanate 2,0/0,2 g every 8 hours followed by oral amoxicillin/clavulanate 875/125 mg every 8 hours in the treatment of adult subjects with complicated skin and skin structure infections'' - MERAK

• Conditions: cSSSIs; MedDRA version: 9.1Level: LLTClassification code 10040872Term: Skin infection

• Registration Number: EUCTR2007-001491-36-IT
• Lead Sponsor: BAYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 21 days
Diagnosis of one of the following SSSI:
- major abscess(es) associated with extensive cellulitis,
- erysipelaa and cellulitis,
- infected pressure ulcers,
- wound infection (including: postsurgical, post traumatic, human bite/clenched fist and animal bite, wound and wound associated with injection drug abuse).
- infected ischemic ulcers with at least one of the following conditions: diabetes mellitus, peripheral vascular disease, paraplegia or peripheral neurophaty.
Presence of at least 3 of the following local signs and symptoms: purulent drainage or discharge, erythema extended > 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

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 <2 monthsi.
Immunosoppression including: known neutropenia , linfopenia, AIDS- defining event and/or concomitant therapy with HAART, chronic treatment > 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 <40 mL/min
Prolungation of QT interval or concomitant use of drugs reported to increase QT interval (class Ia or III antiarrhythmics quinidine, procainamide, amiodarone, sotalol), neuroleptics (haloperidol), tricyclic antidepressive agents, certain antimicrobials (pentamidine, halofantrine), antihistaminic (terfenadine), other drug (cisapride, vincamine IV, depridil, difemanil).
Ipokaliemia
relevant bradycardia
Relevant heart failure
Symptomatic arrhythmias
History of tendon disease/disorder with quinolones
Bacterial infections requiring additional sistemic antibacterial treatment (es. septic arthritis)
Therapy with probenecid
Treatmento with sistemic or topical antibacterial agent for > 24 h in the previous 7 days.
Infection to be due to a MRSA, MRSE, VRE as the single isolated pathogen.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.