Overview

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

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Bayer
Treatments:
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Penicillanic Acid
Piperacillin
Piperacillin, Tazobactam Drug Combination
Tazobactam