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

NCT00828971 | Completed Phase 3

• 2 other identifiers: 126702007-001491-36
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 22

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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].

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Arm 2

ACTIVE COMPARATOR

Drug: Amoxicilline/clavulanic

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

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

Arm 1

Amoxicilline/clavulanic 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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (22)

Unknown Facility

Bagno Di Ripoli, Firenze, 50100, Italy

Location

Unknown Facility

Bari, 70124, Italy

Location

Unknown Facility

Bergamo, 24128, Italy

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Brescia, 25123, Italy

Location

Unknown Facility

Ferrara, 44100, Italy

Location

Unknown Facility

Florence, 50139, Italy

Location

Unknown Facility

Foggia, 71100, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Mantova, 46100, Italy

Location

Unknown Facility

Messina, 98158, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Perugia, 06122, Italy

Location

Unknown Facility

Reggio Emilia, 42100, Italy

Location

Unknown Facility

Rimini, 47900, Italy

Location

Unknown Facility

Roma, 00149, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Torino, 10149, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Varese, 21100, Italy

Location

Unknown Facility

Verona, 37126, Italy

Location

Related Links

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

MeSH Terms

Conditions

Communicable Diseases

Interventions

Moxifloxacin; Amoxicillin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: November 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

IT (22)