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

Infectious Diseases Clinical Trial

— MERAK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828971
• Other study ID #: 12670
• Secondary ID: 2007-001491-36
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2009
• Last updated: December 5, 2014
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).		Test-of-Cure visit [TOC].	No
Secondary	Clinical response assessed by the investigator on treatment Day 3-5		Day 3-5	No
Secondary	Clinical response assessed by the investigator at the end-of-therapy (EOT).		At the end-of-therapy (EOT)	No
Secondary	Time to switch from oral to IV therapy		Day of switch from oral to IV therapy	No
Secondary	Bacteriological response (for microbiologically valid population) at the EOT and TOC		At the end-of-therapy (EOT), Test-of-Cure visit [TOC].	No

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