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

Bayer

Status and phase

Completed

Phase 3

Conditions

Infectious Diseases

Treatments

Drug: Amoxicilline/clavulanic

Drug: Avelox (Moxifloxacin, BAY12-8039)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00828971

12670

2007-001491-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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