Prospective, multicenter, double-blind, randomized study to evaluate the safety and efficacy of BAY 12-8039 (moxifioxacin) 400 mg administered sequentially (intravenously / orally) every 24 hours compared with piperacillin / tazobactam 3.375 grams intravenously every 6 hours, followed of oral suspension of amoxicillin / clavulanic acid 800 mg every 12 hours for the treatment of patients with complicated skin and soft tissue infections.

Not Applicable

• Conditions: -L039 Cellulitis, unspecified; Cellulitis, unspecified; L039

• Registration Number: PER-001-03
• Lead Sponsor: BAYER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-02-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Male or female inpatients> 18 years of age. Women
Potentially fertile should have a negative pregnancy test and sexually active women should use an acceptable contraceptive method (hormonal or barrier) while the treatment lasts.
Diagnosis of skin and soft tissue infections that can be confirmed or suspected based on a Gram stain.
The duration of treatment of skin / soft tissue infection will be
at least 7 days

Exclusion Criteria

Patients with uncomplicated skin and soft tissue infections that do not
require hospitalization or initial treatment with intravenous antibiotics.
Known hypersensitivity to any of the study medications including penicillins and cephalosporins.
History of hypersensitivity to multivitamin concentrates for infusion or preexisting hypervitaminosis. Background of phenylketonuria.
Pregnant women, breastfeeding or in which pregnancy can not be excluded.
Renal insufficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The clinical response to the therapy will be based on serial examinations of the patient to determine the effect of the therapy on the signs and symptoms of the infection.<br>Measure:Efficacy of 2 sequential treatment regimens for the treatment of adult patients with complicated skin and soft tissue infections.<br>Timepoints:14 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:not contemplated<br>Measure:not contemplated<br>Timepoints:not contemplated<br>