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

Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
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: 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.

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: 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.


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

Locations and Contacts

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

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 results for studies related to marketed products

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

Page last updated: October 19, 2009

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