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

Phase 3

Completed

• Conditions: Infectious Diseases
• Interventions: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Amoxicilline/clavulanic

• Registration Number: NCT00828971
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Avelox (Moxifloxacin, BAY12-8039)	-
Arm 2	Amoxicilline/clavulanic	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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].
Clinical response assessed by the investigator on treatment Day 3-5	Day 3-5