Status:
COMPLETED
A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs
Lead Sponsor:
Bayer
Conditions:
Infectious Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 complicat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00828971
Start Date
November 1 2008
End Date
October 1 2009
Last Update
December 8 2014
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Bagno Di Ripoli, Firenze, Italy, 50100
2
Bari, Italy, 70124
3
Bergamo, Italy, 24128
4
Bologna, Italy, 40138