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A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs
This study is currently recruiting participants.
Verified by Bayer, June 2009
First Received: January 23, 2009   Last Updated: June 23, 2009   History of Changes
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00828971
  Purpose

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.


Condition Intervention Phase
Infectious Diseases
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Amoxicilline/clavulanic
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Open Label, Active Comparator, Multicenter, National Trial to Compare the Efficacy and Safety of Sequential IV/PO Moxifloxacin 400 mg Once Daily Versus IV Amoxicillin/Clavulanate 2,0/0,2 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanate 875/125 mg Every 8 Hours in the Treatment of Adult Subjects With Complicated Skin and Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]). [ Time Frame: Test-of-Cure visit [TOC]. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response assessed by the investigator on treatment Day 3-5 [ Time Frame: Day 3-5 ] [ Designated as safety issue: No ]
  • Clinical response assessed by the investigator at the end-of-therapy (EOT). [ Time Frame: At the end-of-therapy (EOT) ] [ Designated as safety issue: No ]
  • Time to switch from oral to IV therapy [ Time Frame: Day of switch from oral to IV therapy ] [ Designated as safety issue: No ]
  • Bacteriological response (for microbiologically valid population) at the EOT and TOC [ Time Frame: At the end-of-therapy (EOT), Test-of-Cure visit [TOC]. ] [ Designated as safety issue: No ]

Estimated Enrollment: 868
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
Arm 2: Active Comparator 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. 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
  4. 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
  5. 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 (blands) regardless of total peripheral WBC count
    • C-reactive protein (CRP) >20 mg/L

Exclusion Criteria:

  1. 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).
  2. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828971

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Italy
Not yet recruiting
Bologna, Italy, 40138
Not yet recruiting
Torino, Italy, 10149
Recruiting
Genova, Italy, 16132
Not yet recruiting
Varese, Italy, 21100
Not yet recruiting
Brescia, Italy, 25123
Not yet recruiting
Mantova, Italy, 46100
Not yet recruiting
Bergamo, Italy, 24128
Not yet recruiting
Reggio Emilia, Italy, 42100
Not yet recruiting
Udine, Italy, 33100
Not yet recruiting
Verona, Italy, 37126
Not yet recruiting
Padova, Italy, 35128
Not yet recruiting
Rimini, Italy, 47900
Recruiting
Napoli, Italy, 80131
Not yet recruiting
Roma, Italy, 00149
Not yet recruiting
Bari, Italy, 70124
Not yet recruiting
Firenze, Italy, 50126
Not yet recruiting
Roma, Italy, 00168
Recruiting
Firenze, Italy, 50139
Not yet recruiting
Perugia, Italy, 06156
Not yet recruiting
Foggia, Italy, 71100
Not yet recruiting
Messina, Italy, 98165
Not yet recruiting
Ferrara, Italy, 44100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers: 12670, 2007-001491-36, MERAK
Study First Received: January 23, 2009
Last Updated: June 23, 2009
ClinicalTrials.gov Identifier: NCT00828971     History of Changes
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Bayer:
Complicated skin and skin structure infections
cSSSI

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Bacterial Agents
Amoxicillin
Moxifloxacin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Moxifloxacin
Therapeutic Uses
Clavulanic Acid
Enzyme Inhibitors
Amoxicillin-Potassium Clavulanate Combination
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009