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

NCT ID: NCT00828971

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-10-31

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.

Conditions

Infectious Diseases

Keywords

Complicated skin and skin structure infections; cSSSI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type: DRUG

Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.

Arm 2

Group Type: ACTIVE_COMPARATOR

Amoxicilline/clavulanic

Intervention Type: DRUG

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

Interventions

Avelox (Moxifloxacin, BAY12-8039)

Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.

Intervention Type: DRUG

Amoxicilline/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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Bagno Di Ripoli, Firenze, Italy

Bari, , Italy

Bergamo, , Italy

Bologna, , Italy

Brescia, , Italy

Ferrara, , Italy

Florence, , Italy

Foggia, , Italy

Genova, , Italy

Mantova, , Italy

Messina, , Italy

Napoli, , Italy

Padua, , Italy

Perugia, , Italy

Reggio Emilia, , Italy

Rimini, , Italy

Roma, , Italy

Roma, , Italy

Torino, , Italy

Udine, , Italy

Varese, , Italy

Verona, , Italy

Countries

Italy

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2007-001491-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12670

Identifier Type: -

Identifier Source: org_study_id