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

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

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.

Study Overview

• Status: Completed
• Conditions: Infectious Diseases
• Intervention / Treatment: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Amoxicilline/clavulanic

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • 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
  • Firenze
    • Bagno di Ripoli, Firenze, Italy, 50100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Clinical response assessed by the investigator on treatment Day 3-5	Day 3-5
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].

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Complicated skin and skin structure infections; cSSSI
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Amoxicillin
• Other Study ID Numbers: 12670; 2007-001491-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No