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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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abscess; Wound Infection; Diabetic Foot; Ulcer

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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.

Clinical Details

Official title: A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects With Complicated Skin and Skin Structure Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population

Secondary outcome:

Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population

Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population

Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population

Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population

Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population

Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms

Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population

Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms

Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population

Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms

Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Graz 8036, Austria

Wien 1090, Austria

Bornem 2880, Belgium

Bruxelles - Brussel 1070, Belgium

Bruxelles - Brussel 1090, Belgium

Edegem 2650, Belgium

Dobrich 9300, Bulgaria

Pleven 5800, Bulgaria

Ruse 7002, Bulgaria

Sofia 1309, Bulgaria

Sofia 1431, Bulgaria

Sofia 1606, Bulgaria

Annecy 74000, France

Avignon 84025, France

Boulogne Sur Mer 62321, France

Denain 59220, France

Grenoble 38043, France

Le Grau Du Roi 30240, France

Nevers 58000, France

Quimper 29000, France

Tourcoing 59280, France

Hamburg 20246, Germany

Athens 115 27, Greece

Athens 124 62, Greece

Rio Patras 265 00, Greece

Thessaloniki 546 36, Greece

Budapest 1027, Hungary

Debrecen 4032, Hungary

Györ 9024, Hungary

Kaposvar 7400, Hungary

Szekesfehervar 8000, Hungary

Veszprem 8200, Hungary

Dublin 7, Ireland

Dublin 9, Ireland

Dublin DUBLIN 4, Ireland

Galway, Ireland

Sligo, Ireland

Haifa 31096, Israel

Tel Hashomer 52621, Israel

Chieti 66013, Italy

Milano 20122, Italy

Pavia 27100, Italy

Roma 00167, Italy

Siena 53100, Italy

Daugavpils LV-5417, Latvia

Liepaja LV 3400, Latvia

Riga 1002, Latvia

Riga 1005, Latvia

Riga LV-1038, Latvia

Valmiera LV-4201, Latvia

Kaunas LT-3007, Lithuania

Siauliai LT-76231, Lithuania

Ukmerge LT-20184, Lithuania

Vilnius 10207, Lithuania

Alkmaar 1800 AM, Netherlands

Eindhoven 5600 PD, Netherlands

Kraków 30-501, Poland

Lublin 20-718, Poland

Lublin 20-954, Poland

Lublin 20-081, Poland

Poznan 60-479, Poland

Pulawy 24-100, Poland

Warszawa 02-097, Poland

Bucharest 050099, Romania

Bucharest 022328, Romania

Bucharest 040215, Romania

Cluj-Napoca 400006, Romania

Iasi 700106, Romania

Moscow 197046, Russian Federation

Moscow 123567, Russian Federation

Moscow 125206, Russian Federation

Moscow 127486, Russian Federation

Moscow 129327, Russian Federation

Moscow 129110, Russian Federation

Smolensk 214019, Russian Federation

St. Petersburg 198099, Russian Federation

St. Petersburg, Russian Federation

Yaroslavl 150003, Russian Federation

Barcelona 08025, Spain

Barcelona 08036, Spain

Madrid 28007, Spain

Madrid 28034, Spain

Madrid 28047, Spain

Salamanca 37007, Spain

Ivano-Frankivsk 76000, Ukraine

Kiev 01021, Ukraine

Kiev 01023, Ukraine

Kiev 01103, Ukraine

Kiev 01133, Ukraine

Lviv 79659, Ukraine

Odessa 65065, Ukraine

Uzhgorod 88018, Ukraine

Manchester M13 9WL, United Kingdom

York YO13 8HE, United Kingdom

Oviedo, Asturias 33006, Spain

Athens, Attica 106 76, Greece

Athens, Attica 11527, Greece

Mannheim, Baden-Württemberg 68135, Germany

München, Bayern 81377, Germany

Terrassa (Barcelona), Catalunya 08221, Spain

Wilton, Cork, Ireland

Johannesburg, Gauteng 2157, South Africa

Pretoria, Gauteng 0084, South Africa

London, Greater london SE5 9RS, United Kingdom

Winchester, Hampshire SO22 5DG, United Kingdom

Darmstadt, Hessen 64297, Germany

Wiesbaden, Hessen 65191, Germany

Inverness, Highland IV2 3UJ, United Kingdom

Edinburgh, Lothian EH16 4SA, United Kingdom

Hannover, Niedersachsen 30625, Germany

Bochum, Nordrhein-Westfalen 44791, Germany

Münster, Nordrhein-Westfalen 48149, Germany

Mainz, Rheinland-Pfalz 55101, Germany

Magdeburg, Sachsen-Anhalt 39120, Germany

Lübeck, Schleswig-Holstein 23538, Germany

Graz, Steiermark 8036, Austria

Glasgow, Stratchclyde G4 0SF, United Kingdom

Newcastle Upon Tyne, Tyne and Wear NE7 7DN, United Kingdom

Leeds, West Yorkshire LS1 3EX, United Kingdom

Cape Town, Western Cape 7505, South Africa

Cape Town, Western Cape 7531, South Africa

Cape Town, Western Cape 7925, South Africa

Worcester, Western Cape 6850, South Africa

Additional Information

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Starting date: September 2006
Last updated: November 3, 2014

Page last updated: August 23, 2015

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