Trial Condition(s):

Infectious Diseases

A study to assess efficacy and safety of IV/PO moxifloxacin in the treatment of cSSSIs (MERAK)

Bayer Identifier:

12670

ClinicalTrials.gov Identifier:

NCT00828971

EudraCT Number:

2007-001491-36

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
16
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10149

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A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

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A.O. Carlo Poma

Mantova, Italy, 46100

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A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

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A.O.U. Policlinico Consorziale

Bari, Italy, 70124

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A.O.U. Careggi

Firenze, Italy, 50139

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A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

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A.O.U. di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

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IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

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A.O. Spedali Civili

Brescia, Italy, 25123

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A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

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A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

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A.O.U. Integrata Verona

Verona, Italy, 37126

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A.O. di Padova

Padova, Italy, 35128

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A.O.U. di Ferrara

Ferrara, Italy, 44100

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A.O. Domenico Cotugno

Napoli, Italy, 80131

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IRCCS Ist Spallanzani

Roma, Italy, 00149

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AUSL 10 Firenze - Toscana

Bagno di Ripoli, Italy, 50100

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Università Cattolica del Sacro Cuore

Roma, Italy, 00168

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A.O. di Perugia

Perugia, Italy, 06122

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A.O. Papardo di Messina

Messina, Italy, 98158

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AUSL Rimini - Emilia Romagna

Rimini, Italy, 47900

Trial Design