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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00828971
First received: January 23, 2009
Last updated: July 16, 2013
Last verified: July 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ]

Enrollment: 16
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828971

Locations
Italy
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00828971     History of Changes
Other Study ID Numbers: 12670, 2007-001491-36
Study First Received: January 23, 2009
Last Updated: July 16, 2013
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Communicable Diseases
Infection
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014