Infectious Diseases
Conditions
Keywords
Complicated skin and skin structure infections, cSSSI
Brief summary
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.
Interventions
Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
DRUGAmoxicilline/clavulanic
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
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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]. |
Countries
Italy
Outcome results
None listed