A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs

Study Overview
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Brief Summary
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The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.

Official Title
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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

Conditions
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Infectious Diseases

Intervention / Treatment
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* Drug: Avelox (Moxifloxacin, BAY12-8039)
* Drug: Amoxicilline/clavulanic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Men or women of age >/= 18 years with a diagnosis of bacterial skin and skin structure infection that requires Hospitalization Initial parenteral therapy for at least 48 hours Complicated by at least one of the following criteria: Involvement of deep soft tissues (e.g. fascial, muscle layers) Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement Association with a significant underlying disease that may complicate response to treatment. Presence of SIRS (Systemic Inflammatory Response Syndrome) defined as two or more of the following signs or symptoms: - temperature > 38.3°C or < 36°C - white blood cell count > 12.000/mmc or < 4.000 or > 10% bands - pulse rate > 90 beats/min - respiratory rate > 20178 - systolic blood pressure </= 90 mmgHg - decreased capillary refill/mottling > 2 seconds - lactate > 2 mmol/L - altered mental status - hyperglycemia > 120 mg/dl or 7.7 mmol/L in the absence of diabetes - protein C (CPR) > 20 mg/L (VR 0-5)3. Duration of infection < 21 days Diagnosis of one of the following skin and skin structure infections: major abscess(es) associates with extensive cellulitis erysipelas and cellulitis infected pressure ulcers(s) wound infections including: post surgical (surgical incision), 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 - Conditions pre-disposing to pressure scores such as paraplegia or peripheral neuropathy Presence of at least 3 of the following local signs and symptoms purulent drainage or discharge erythema extended >1 cm from the wound edge fluctuance pain or tenderness to palpation swelling or induration fever defined as body temperature > 37.5°C (axillary), > 38°C (orally), > 38.5°C (tympanically), or > 39°C (rectally). OR Elevated total peripheral white blood cell (WBC) count> 12,000/mm3 OR > 15% immature neutrophils (blends) regardless of total peripheral WBC count C-reactive protein (CRP) >20 mg/L Exclusion Criteria: Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug). The following skin and skin structure infections: Necrotizing fasciitis including Fournier's gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis. Burn wound infections. Secondary infections of a chronic skin disease (eg, atopic dermatitis). Infection of prosthetic materials. Subjects with removal of a prosthetic device involved in an infection should not be included. Infections where a surgical procedure alone is definitive therapy. Subjects with uncomplicated skin and skin structure infections including

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Avelox (Moxifloxacin, BAY12-8039)<br>* Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.<br>|
| Active Comparator: Arm 2<br> | Drug: Amoxicilline/clavulanic<br>* IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]). |  | Test-of-Cure visit [TOC]. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response assessed by the investigator on treatment Day 3-5 |  | Day 3-5 | 
| Clinical response assessed by the investigator at the end-of-therapy (EOT). |  | At the end-of-therapy (EOT) | 
| Time to switch from oral to IV therapy |  | Day of switch from oral to IV therapy | 
| Bacteriological response (for microbiologically valid population) at the EOT and TOC |  | At the end-of-therapy (EOT), Test-of-Cure visit [TOC]. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complicated skin and skin structure infections, cSSSI