Trial Condition(s):

Abscess, Wound Infection, Diabetic Foot, Ulcer

Comparison of sequential IV/PO moxifloxacin with IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in patients with a complicated skin and skin structure infection

Bayer Identifier:

11974

ClinicalTrials.gov Identifier:

NCT00402727

EudraCT Number:

2006-001599-18

Study Completed

Trial Purpose

Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.

Inclusion Criteria
- Written informed consent
 - Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires 
 -- Hospitalization and
 -- Initial parenteral therapy for at least 48 hours and
 -- Meets at least one of the following criteria:
 --- Involvement of deep soft tissue (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. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
 - Duration of infection < 21 days
 - Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
 -- Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
 -- Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
 -- Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
 --- Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
 --- In addition, post-surgical/trauma wound infections must meet the following criteria:
 ---- Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
 ---- At least one of the following criteria:
 ----- Purulent drainage from the deep incision/trauma
 ----- Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
 ---- At least one of the following signs and symptoms:
 ----- Localized pain or tenderness
 ----- Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
 ----- Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
 ---- Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
 ---- Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI) 
 -- Infected ischemic ulcers with at least one of the following conditions:
 --- Peripheral vascular disease
 --- Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
 --- Presence of at least 3 of the following signs or symptoms:
 ---- Purulent drainage or discharge
 ---- Erythema extending > 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 (bands) regardless of total peripheral WBC count
 ---- C reactive protein (CRP) >20 mg/L
 - Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
 - Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
 - Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
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 Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
 -- Burn wound infections
 -- Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
 -- Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). 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 folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
 - Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
 - Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
 - Severe, life threatening disease with a life expectancy of less than 2 months
 - Immunosuppression including:
 -- Known neutropenia (neutrophil count < 1000/µL)
 -- Known lymphopenia with absolute CD4+ T cell count < 200/mm3
 -- Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
 -- Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
 -- Any other congenital or acquired immune defect or immunosuppression
 - Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
 - Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
 - Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval  (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
 - Uncorrected hypokalemia
 - Clinically relevant bradycardia
 - Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
 - Previous history of symptomatic arrhythmias
 - Previous history of tendon disease/disorder with quinolones
 - Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
 - Requiring therapy with probenecid
 - Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
 - Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
 - Previous enrolment in this study
 - Participation in any clinical investigational drug study within 4 weeks of screening
 - Previous history of seizure disorders

Trial Summary

Enrollment Goal
813
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

Klinikum Mannheim gGmbH

Mannheim, Germany, 68135

Status
Terminated
 
Locations

Universitätsklinikum Otto-von Guericke - Magdeburg

Magdeburg, Germany, 39120

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Terminated
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Terminated
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

Status
Terminated
 
Locations

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom, EH16 4SA

Status
Terminated
 
Locations

Raigmore Hospital

Inverness, United Kingdom, IV2 3UJ

Status
Completed
 
Locations

Royal Hampshire County Hospital

Winchester, United Kingdom, SO22 5DG

Status
Terminated
 
Locations

Hopital Beregovoy - Nevers

NEVERS, France, 58000

Status
Terminated
 
Locations

Hopital Henri Duffaut - Avignon

AVIGNON, France, 84025

Status
Terminated
 
Locations

Centre Hospitalier - Denain

DENAIN, France, 59220

Status
Terminated
 
Locations

LE BOUCANET - LE GRAU DU ROI

LE GRAU DU ROI, France, 30240

Status
Terminated
 
Locations

HSK, Dr.-Horst-Schmidt-Kliniken

Wiesbaden, Germany, 65191

Status
Terminated
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 81377

Status
Terminated
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64297

Status
Terminated
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55101

Status
Terminated
 
Locations

Ruhr-Universität-Bochum Medizinische Einrichtungen

Bochum, Germany, 44791

Status
Completed
 
Locations

Leeds General Infirmary

Leeds, United Kingdom, LS1 3EX

Status
Terminated
 
Locations

Kings College Hospital

London, United Kingdom, SE5 9RS

Status
Terminated
 
Locations

York General Hospital

York, United Kingdom, YO13 8HE

Status
Terminated
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Terminated
 
Locations

Glasgow Royal Infirmary

Glasgow, United Kingdom, G4 0SF

Status
Terminated
 
Locations

Raigmore Hospital

Inverness, United Kingdom, IV2 3UJ

Status
Terminated
 
Locations

Centre Hospitalier de Cornouaille - Quimper

QUIMPER, France, 29000

Status
Terminated
 
Locations

Centre Hospitalier

ANNECY, France, 74000

Status
Terminated
 
Locations

Centre Hospitalier Universitaire - Grenoble

GRENOBLE, France, 38043

Status
Terminated
 
Locations

Szpital Wojewodzki w Poznaniu

Poznan, Poland, 60-479

Status
Terminated
 
Locations

Centralny Szpital Kliniczny AM

Warszawa, Poland, 02-097

Status
Completed
 
Locations

Szpital Uniwersytecki w Krakowie

Kraków, Poland, 30-501

Status
Terminated
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-954

Status
Completed
 
Locations

SPSK nr 1

Lublin, Poland, 20-081

Status
Completed
 
Locations

SPZOZ Pulawy

Pulawy, Poland, 24-100

Status
Terminated
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Terminated
 
Locations

Università G.D'Annunzio

Chieti, Italy, 66013

Status
Terminated
 
Locations

Congregazione Figli Immacolata Concezione

Roma, Italy, 00167

Status
Terminated
 
Locations

Hospital de la Mútua de Terrassa

Terrassa (Barcelona), Spain, 08221

Status
Terminated
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

Status
Terminated
 
Locations

Hospital Central de Asturias

Oviedo, Spain, 33006

Status
Terminated
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Terminated
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

Sint-Jozefkliniek

BORNEM, Belgium, 2880

Status
Completed
 
Locations

Centre Hospitalier Général - Boulogne sur Mer

BOULOGNE SUR MER, France, 62321

Status
Terminated
 
Locations

Centre Hospitalier Gustave Dron - Tourcoing

TOURCOING, France, 59280

Status
Terminated
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Terminated
 
Locations

IRCCS Fond. Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Terminated
 
Locations

Hospital Gómez Ulla

Madrid, Spain, 28047

Status
Terminated
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Terminated
 
Locations

Hospital Ramón y Cajal

Madrid, Spain, 28034

Status
Terminated
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
 
Locations

Hospital Clínico de Salamanca

Salamanca, Spain, 37007

Status
Terminated
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Medisch Centrum Alkmaar

ALKMAAR, Netherlands, 1800 AM

Status
Terminated
 
Locations

University of Cape Town

Cape Town, South Africa, 7925

Status
Completed
 
Locations

Sunninghill Hospital

Johannesburg, South Africa, 2157

Status
Completed
 
Locations

University of Stellenbosch

Cape Town, South Africa, 7505

Status
Terminated
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

Maxima Medisch Centrum, locatie Eindhoven

EINDHOVEN, Netherlands, 5600 PD

Status
Terminated
 
Locations

Pretoria Academic Hospital Ethics Committee

Pretoria, South Africa, 0084

Status
Terminated
 
Locations

Pretoria Academic Hospital Ethics Committee

Pretoria, South Africa, 0084

Status
Completed
 
Locations

Tiervlei Trial Centre

Cape Town, South Africa, 7531

Status
Completed
 
Locations

Clinical Projects Research SA

Worcester, South Africa, 6850

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Terminated
 
Locations

MHAT Russe

Ruse, Bulgaria, 7002

Status
Completed
 
Locations

MHATEM N.I. Pirogov

Sofia, Bulgaria, 1606

Status
Terminated
 
Locations

Csolnoky Ferenc Veszprem County Hospital

Veszprem, Hungary, 8200

Status
Completed
 
Locations

Petz Aladar Megyei Korhaz

Györ, Hungary, 9024

Status
Completed
 
Locations

Budai Irgalmasrendi Hospital

Budapest, Hungary, 1027

Status
Completed
 
Locations

Laiko General Hospital of Athens

Athens, Greece, 11527

Status
Terminated
 
Locations

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Status
Terminated
 
Locations

Bureau of Medical Social Expertise

Moscow, Russia, 127486

Status
Completed
 
Locations

City Hospital No 14

St. Petersburg, Russia, 198099

Status
Completed
 
Locations

MBAL-Dobrich

Dobrich, Bulgaria, 9300

Status
Terminated
 
Locations

Military Medical Academy

Sofia, Bulgaria, 1431

Status
Completed
 
Locations

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

IV City Hospital-Sofia

Sofia, Bulgaria, 1606

Status
Terminated
 
Locations

Alexandrovska UMHAT

Sofia, Bulgaria, 1431

Status
Terminated
 
Locations

National Heart Hospital

Sofia, Bulgaria, 1309

Status
Terminated
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Terminated
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Terminated
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Terminated
 
Locations

Fejer megyei Szent Gyorgy Korhaz

Szekesfehervar, Hungary, 8000

Status
Completed
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Somogy County Hospital "Kaposi Mor"

Kaposvar, Hungary, 7400

Status
Completed
 
Locations

University General Hospital of Patras

Rio Patras, Greece, 265 00

Status
Terminated
 
Locations

Attikon University General Hospital of Attica

Athens, Greece, 124 62

Status
Terminated
 
Locations

Evangelismos General Hospital of Athens

Athens, Greece, 106 76

Status
Completed
 
Locations

Clinical Hospital for Emergency Care n.a. N.V.Solovyov

Yaroslavl, Russia, 150003

Status
Completed
 
Locations

Moscow Scintific Clinical Institute named after Vladimirsky

Moscow, Russia, 129110

Status
Terminated
 
Locations

Lviv Emergency Hospital

Lviv, Ukraine, 79659

Status
Completed
 
Locations

Central City Clinical Hospital

Kiev, Ukraine, 01023

Status
Completed
 
Locations

Regional Clinical Hospital

Ivano-Frankivsk, Ukraine, 76000

Status
Completed
 
Locations

Regional Clinical Hospital

Odessa, Ukraine, 65065

Status
Completed
 
Locations

Kaunas Medical University Hospital

Kaunas, Lithuania, LT-3007

Status
Completed
 
Locations

Siauliai County Hospital

Siauliai, Lithuania, LT-76231

Status
Completed
 
Locations

University Hospital of Vilnus City

Vilnius, Lithuania, 10207

Status
Completed
 
Locations

Latvian Maritime Medicine Center

Riga, Latvia, 1005

Status
Completed
 
Locations

Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

Status
Completed
 
Locations

Sligo General Hospital

Sligo, Ireland

Status
Terminated
 
Locations

Cork University Hospital

Wilton, Ireland

Status
Terminated
 
Locations

Beaumont Hospital

Dublin, Ireland, 9

Status
Terminated
 
Locations

St Vincents University Hospital

Dublin, Ireland, DUBLIN 4

Status
Terminated
 
Locations

Dermato Venerology Clinical Hospital

Bucharest, Romania, 040215

Status
Terminated
 
Locations

Laiko General Hospital of Athens

Athens, Greece, 115 27

Status
Terminated
 
Locations

Scientific Research Institute for Traumatology and Orthopaed

Moscow, Russia, 197046

Status
Terminated
 
Locations

Municipal Clinical Hospital N50

Moscow, Russia, 125206

Status
Completed
 
Locations

Central Clinical Hospital no 1 OAO RZD

Moscow, Russia, 123567

Status
Completed
 
Locations

Institute of Emergency Care n.a. Janelidze

St. Petersburg, Russia

Status
Terminated
 
Locations

Smolensk Medical Academy

Smolensk, Russia, 214019

Status
Completed
 
Locations

City Clinical Hospital N 20

Moscow, Russia, 129327

Status
Terminated
 
Locations

Main Military Clinical Hospital

Kiev, Ukraine, 01133

Status
Completed
 
Locations

City Hospital no 12

Kiev, Ukraine, 01103

Status
Completed
 
Locations

Uzhgorod Regional Hospital

Uzhgorod, Ukraine, 88018

Status
Terminated
 
Locations

Military-Medical Dept. of Scurity Service

Kiev, Ukraine, 01021

Status
Terminated
 
Locations

Ukmerge Hospital

Ukmerge, Lithuania, LT-20184

Status
Completed
 
Locations

Riga 2nd City Hospital

Riga, Latvia, 1002

Status
Terminated
 
Locations

Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, 1002

Status
Completed
 
Locations

Valmiera Hospital

Valmiera, Latvia, LV-4201

Status
Completed
 
Locations

Riga Clinical Hospital "Gailezers"

Riga, Latvia, LV-1038

Status
Completed
 
Locations

Fundeni Clinical Institute

Bucharest, Romania, 022328

Status
Completed
 
Locations

Central Hospital of Liepaja

Liepaja, Latvia, LV 3400

Status
Completed
 
Locations

Mater Misericordiae University Hospital

Dublin, Ireland, 7

Status
Terminated
 
Locations

University College Hospital

Galway, Ireland

Status
Terminated
 
Locations

Clinical Emergency County Hospital

Cluj-Napoca, Romania, 400006

Status
Completed
 
Locations

"Sfantul Spiridon" Emergency Clinical County Hospital

Iasi, Romania, 700106

Status
Completed
 
Locations

Spitatul Universitar de Urgenta Bucaresti

Bucharest, Romania, 050099

Status
Completed
 

Trial Design