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Trial record 44 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

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

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ClinicalTrials.gov Identifier: NCT00828971
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE January 23, 2009
First Posted Date  ICMJE January 26, 2009
Last Update Posted Date December 8, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
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]. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00828971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
  • Clinical response assessed by the investigator on treatment Day 3-5 [ Time Frame: Day 3-5 ]
  • Clinical response assessed by the investigator at the end-of-therapy (EOT). [ Time Frame: At the end-of-therapy (EOT) ]
  • Time to switch from oral to IV therapy [ Time Frame: Day of switch from oral to IV therapy ]
  • Bacteriological response (for microbiologically valid population) at the EOT and TOC [ Time Frame: At the end-of-therapy (EOT), Test-of-Cure visit [TOC]. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infectious Diseases
Intervention  ICMJE
  • Drug: Avelox (Moxifloxacin, BAY12-8039)
    Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Active Comparator: Arm 2
    Intervention: Drug: Amoxicilline/clavulanic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2013)
16
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2009)
868
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00828971
Other Study ID Numbers  ICMJE 12670
2007-001491-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP