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Trial record 94 of 506 for:    MOXIFLOXACIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828971
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : December 8, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Infectious Diseases Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Amoxicilline/clavulanic Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.

Active Comparator: Arm 2 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

Primary Outcome Measures :
  1. 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]. ]

Secondary Outcome Measures :
  1. Clinical response assessed by the investigator on treatment Day 3-5 [ Time Frame: Day 3-5 ]
  2. Clinical response assessed by the investigator at the end-of-therapy (EOT). [ Time Frame: At the end-of-therapy (EOT) ]
  3. Time to switch from oral to IV therapy [ Time Frame: Day of switch from oral to IV therapy ]
  4. Bacteriological response (for microbiologically valid population) at the EOT and TOC [ Time Frame: At the end-of-therapy (EOT), Test-of-Cure visit [TOC]. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00828971

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Bagno di Ripoli, Firenze, Italy, 50100
Bari, Italy, 70124
Bergamo, Italy, 24128
Bologna, Italy, 40138
Brescia, Italy, 25123
Ferrara, Italy, 44100
Firenze, Italy, 50139
Foggia, Italy, 71100
Genova, Italy, 16132
Mantova, Italy, 46100
Messina, Italy, 98158
Napoli, Italy, 80131
Padova, Italy, 35128
Perugia, Italy, 06122
Reggio Emilia, Italy, 42100
Rimini, Italy, 47900
Roma, Italy, 00149
Roma, Italy, 00168
Torino, Italy, 10149
Udine, Italy, 33100
Varese, Italy, 21100
Verona, Italy, 37126
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT00828971     History of Changes
Other Study ID Numbers: 12670
2007-001491-36 ( EudraCT Number )
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Complicated skin and skin structure infections
Additional relevant MeSH terms:
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Communicable Diseases
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
beta-Lactamase Inhibitors