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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infectious Diseases

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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


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.

Clinical Details

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

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.


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 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

Locations and Contacts

Bari 70124, Italy

Bergamo 24128, Italy

Bologna 40138, Italy

Brescia 25123, Italy

Ferrara 44100, Italy

Firenze 50139, Italy

Foggia 71100, Italy

Genova 16132, Italy

Mantova 46100, Italy

Messina 98158, Italy

Napoli 80131, Italy

Padova 35128, Italy

Perugia 06122, Italy

Reggio Emilia 42100, Italy

Rimini 47900, Italy

Roma 00149, Italy

Roma 00168, Italy

Torino 10149, Italy

Udine 33100, Italy

Varese 21100, Italy

Verona 37126, Italy

Bagno di Ripoli, Firenze 50100, Italy

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

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

Click here to find results for studies related to Bayer Healthcare products.

Starting date: November 2008
Last updated: December 5, 2014

Page last updated: August 20, 2015

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