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| Sponsored by: |
Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00402727 |
Purpose
Patients who are considered suitable by their physicians, to take part in this research, will have a physical examination (including an 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: IV/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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abscess Wound Infection Diabetic Foot Ulcer |
Drug: Moxifloxacin intravenous and per os Drug: Piperacillin/Tazobactam intravenous, Amoxicillin/Clavulanic acid per os |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 804 |
| Study Start Date: | September 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Moxifloxacin intravenous and per os
Moxifloxacin, 400 mg administered intravenous once daily followed by Moxifloxacin 400 mg oral tablets once daily
|
| Arm 2: Active Comparator |
Drug: Piperacillin/Tazobactam intravenous, Amoxicillin/Clavulanic acid per os
Piperacillin/Tazobactam, 4.0/0.5g administered intravenous three times daily followed by amoxicillin/clavulanic acid oral tablets, 875/125mg twice daily.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
Meets at least one of the following criteria:
Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
Fever (see below) AND The incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
d. Infected ischemic ulcers with at least one of the following conditions:
Presence of at least 3 of the following signs or symptoms:
Fever, defined as body temperature
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:
The following skin and skin structure infections:
Immunosuppression including:
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])
Contacts and Locations
Show 126 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 11974, EudraCT 2006-001599-18 |
| Study First Received: | November 21, 2006 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00402727 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Disorders of Environmental Origin Clavulanic Acids Piperacillin-tazobactam combination product Diabetic Angiopathies Anti-Bacterial Agents Moxifloxacin Clavulanic Acid Diabetes Complications Wound Infection Foot Ulcer Amoxicillin Skin Diseases Diabetic Neuropathies |
Ulcer Diabetes Mellitus Vascular Diseases Wounds and Injuries Endocrine System Diseases Tazobactam Penicillanic Acid Abscess Piperacillin Endocrinopathy Skin Ulcer Leg Ulcer Diabetic Foot |
|
Anti-Infective Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action Disorders of Environmental Origin Clavulanic Acids Piperacillin-tazobactam combination product Infection Diabetic Angiopathies Anti-Bacterial Agents Moxifloxacin Therapeutic Uses Clavulanic Acid Cardiovascular Diseases Diabetes Complications Wound Infection |
Foot Ulcer Amoxicillin Skin Diseases Diabetic Neuropathies Vascular Diseases Wounds and Injuries Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Tazobactam Pharmacologic Actions Penicillanic Acid Piperacillin Skin Ulcer Leg Ulcer |