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

Condition(s) targeted: Infectious Diseases

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Amoxicilline/clavulanic (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).

Secondary outcome:

Clinical response assessed by the investigator on treatment Day 3-5

Clinical response assessed by the investigator at the end-of-therapy (EOT).

Time to switch from oral to IV therapy

Bacteriological response (for microbiologically valid population) at the EOT and TOC

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Written informed consent

2. 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

- 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

4. 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

5. 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 (blands) regardless of total peripheral WBC count

- C-reactive protein (CRP) >20 mg/L

Exclusion Criteria:

1. 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).

2. 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Bologna 40138, Italy; Not yet recruiting

Torino 10149, Italy; Not yet recruiting

Genova 16132, Italy; Recruiting

Varese 21100, Italy; Not yet recruiting

Brescia 25123, Italy; Not yet recruiting

Mantova 46100, Italy; Not yet recruiting

Bergamo 24128, Italy; Not yet recruiting

Reggio Emilia 42100, Italy; Not yet recruiting

Udine 33100, Italy; Not yet recruiting

Verona 37126, Italy; Not yet recruiting

Padova 35128, Italy; Not yet recruiting

Ferrara 44100, Italy; Not yet recruiting

Napoli 80131, Italy; Recruiting

Roma 00149, Italy; Not yet recruiting

Bari 70124, Italy; Not yet recruiting

Firenze 50126, Italy; Not yet recruiting

Roma 00168, Italy; Not yet recruiting

Firenze 50139, Italy; Recruiting

Perugia 06156, Italy; Not yet recruiting

Foggia 71100, Italy; Not yet recruiting

Messina 98158, Italy; Not yet recruiting

Rimini 47900, Italy; Not yet recruiting

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Starting date: November 2008
Ending date: December 2009
Last updated: September 15, 2009