A prospective, randomized, double dummy, double blind, multinational, multicenter trial comparing the safety and efficacy of sequential (intravenous/oral) moxifloxacin 400 mg once daily 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 (RELIEF Study) - RELIEF

Phase 1

• Conditions: complicated skin and skin structure Infections; MedDRA version: 8.1 Level: HLT Classification code 10040786 Term: Skin structures and soft tissue infections

• Registration Number: EUCTR2006-001599-18-GB
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-25
• Study Completion: 2008-06-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects must meet all of the following inclusion criteria:
1.Written informed consent.
2.Men or women of age >= 18 years of age with a diagnosis of bacterial skin and skin structure infection that requires
a.Hospitalization
and
b.Initial parenteral therapy for at least 48 hours
and
c.Meets at least one of the following criteria:
?Involvement of deep soft tissue (eg, fascial, muscle layers).(42)
?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 (ie, congestive heart disease), diabetes mellitus, hepatic (ie, cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease.
3.Duration of infection < 21 days.
4.Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
a.Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage.
b.Diabetic foot infection of mild to severe intensity (PEDIS grade 2-4)(43) 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.
c.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 (42):
•Involvement of deep soft tissues (eg, 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:
a.Localized pain or tenderness.
b.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 SSI by a surgeon or attending physician.
?Bite wounds/clenched fist infec

Exclusion Criteria

Subjects with any of the following will be excluded from the study:
1.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).
2.The following skin and skin structure infections:
a.Necrotizing fasciitis including Fournier’s gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis.
b.Burn wound infections.
c.Secondary infections of a chronic skin disease (eg, atopic dermatitis).
d.Infection of prosthetic materials (eg, 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.
e.Infections where a surgical procedure alone is definitive therapy.
f.Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis.
3.Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients.
4.Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid.
5.Severe, life threatening disease with a life expectancy of less than 2 months.
6.Immunosuppression including:
a.Known neutropenia (neutrophil count < 1000/µL).
b.Known lymphopenia with absolute CD4+ T cell count < 200/mm3.
c.AIDS-defining event and/or concomitant therapy with HAART.
d.Chronic treatment (>= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent).
e.Any other congenital or acquired immune defect or immunosuppression.
7.Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN).
8.Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min (see Cockcroft-Gault formula in Section 10.3).
9.Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (eg, Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [eg., haloperidol], tricyclic antidepressive agents, certain antimicrobials [eg, pentamidine, halofantrine], certain antihistaminics [eg., terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil]).
10.Uncorrected hypokalemia.
11.Clinically relevant bradycardia.
12.Clinically relevant heart failure with reduced left ventricular ejection fraction (ie, below 40%).
13.Previous history of symptomatic arrhythmias.
14.Previous history of tendon disease/disorder with quinolones.
15.Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, eg, underlying septic arthritis.
16.Requiring therapy with probenecid.
17.Treatment with a systemic or topical antibacterial agent for >

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified