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

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
Status
LocationsStatus
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10149

Status
Terminated
 
Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

Status
Terminated
 
Locations

A.O. Carlo Poma

Mantova, Italy, 46100

Status
Terminated
 
Locations

A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

Status
Terminated
 
Locations

A.O.U. Policlinico Consorziale

Bari, Italy, 70124

Status
Terminated
 
Locations

A.O.U. Careggi

Firenze, Italy, 50139

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

Status
Terminated
 
Locations

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

Bologna, Italy, 40138

Status
Terminated
 
Locations

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

Genova, Italy, 16132

Status
Completed
 
Locations

A.O. Spedali Civili

Brescia, Italy, 25123

Status
Terminated
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Terminated
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Terminated
 
Locations

A.O.U. Integrata Verona

Verona, Italy, 37126

Status
Terminated
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Terminated
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44100

Status
Terminated
 
Locations

A.O. Domenico Cotugno

Napoli, Italy, 80131

Status
Completed
 
Locations

IRCCS Ist Spallanzani

Roma, Italy, 00149

Status
Completed
 
Locations

AUSL 10 Firenze - Toscana

Bagno di Ripoli, Italy, 50100

Status
Terminated
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Terminated
 
Locations

A.O. di Perugia

Perugia, Italy, 06122

Status
Terminated
 
Locations

A.O. Papardo di Messina

Messina, Italy, 98158

Status
Terminated
 
Locations

AUSL Rimini - Emilia Romagna

Rimini, Italy, 47900

Status
Completed
 

Trial Design