Trial Condition(s):
A study to assess efficacy and safety of IV/PO moxifloxacin in the treatment of cSSSIs (MERAK)
12670
Not Available
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.
- 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
- 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
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Locations ASL TO/2 - Piemonte Torino, Italy, 10149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Circolo e Fond.Macchi Varese, Italy, 21100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Carlo Poma Mantova, Italy, 46100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Consorziale Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Foggia Foggia, Italy, 71100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna - Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Integrata Verona Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Ferrara Ferrara, Italy, 44100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Domenico Cotugno Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Spallanzani Roma, Italy, 00149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 10 Firenze - Toscana Bagno di Ripoli, Italy, 50100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Perugia Perugia, Italy, 06122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Papardo di Messina Messina, Italy, 98158 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Rimini - Emilia Romagna Rimini, Italy, 47900 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2