Multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a 10-day course of therapy with grepafloxacin administered in a dose of 600 mg once per day; against a course of 10 days of therapy with trovafloxacin administered in a dose of 200 mg once per day, in the treatment of subjects with community-acquired pneumonia
- Conditions
- -J189 Pneumonia, unspecifiedPneumonia, unspecifiedJ189
- Registration Number
- PER-051-99
- Lead Sponsor
- GLAXO WELCOME S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Men or women of 18 years of age or older.
• Subjects presenting clinical signs and symptoms consistent with community-acquired pneumonia (CAP); that is, one or more of the following characteristics: pleuritic pain, cough, fever (temperature> 38 ° C) or auscultatory signs such as rales, and / or evidence of consolidation
• Chest x-ray taken within two days before starting the medication in the study, confirming the evidence of pulmonary infiltration or consolidation, which is probably due to pneumonia and for which there is no other cause.
• Ability to read, understand and record information, when applicable.
• A signed and dated written authorization is obtained, in which the subject agrees to participate in the study after having been informed about it.
• Subjects with pneumonia acquired in the hospital or who receive immediate antibiotic therapy through the intravenous route.
• Subjects with bronchial carcinoma, empyema, lung abscess, uncontrolled asthma, pulmonary tuberculosis or cystic fibrosis.
• Subjects who have received potentially effective systemic therapy with an antibiotic in the three days prior to the first dose of the study medication or who are receiving concomitant systemic antibacterial agents. Antibiotic therapy is defined as potentially effective as any antibiotic in which published information indicates that <7 and> 3 days of treatment are effective. In such a case, a subject could be enrolled if he had not received more than a single dose before the therapy within 24 hours of starting the study medication. If the information indicates that the duration of therapy for <3 days may be effective, then a single dose will exclude the subject from the study.
• Subjects that need to start or increase the dose in their steroid therapy. Patients who receive inhaled or intranasal and systemic steroids continuously in doses equivalent to <10 mg / day of prednisolone are not excluded.
• Subjects with a history of hypersensitivity reactions or phototoxicity to any quinolone.
• Pre-menopausal women who do not use an acceptable contraceptive method, pregnant women or those who are breastfeeding.
• Subjects with documented hepatic or renal impairment (liver function tests, urea or creatinine at values 2 times higher than the upper limit of normality *).
• History of convulsions in the last two years, or in habitual treatment for a convulsive disorder.
• Any underlying condition that is known to compromise the subject´s ability to respond to bacterial infection (eg, immune deficiency, neutropenia (<1500 neutrophils / mm ^ *), immunosuppressive medications such as systemic steroids (> 10 mg / day prednisolone) or its equivalent) and ciclosporin, severe and uncontrolled diabetes mellitus, splenectomized subjects, subjects with AIDS).
• Subjects with a history of a gastrointestinal disorder that could affect the absorption of the antibiotic (for example, malabsorption syndrome, inflammatory bowel disease, chronic diarrhea or any gastrointestinal surgery in the three months prior to entering the study).
• Subjects with significant heart disease (including congenital or acquired prolongation of the QT interval, disturbances in electrolyte balance, particularly hypokalemia, clinically relevant bradycardia, clinically relevant congestive heart failure with a reduced left ventricular ejection fraction, or subjects with a history of symptomatic cardiac arrhythmia, pacemaker implant).
• Requirement of a concurrent treatment with terfenadine, astemizole, amitriptyline, cisapride, thioridazine, class A and DI antiarrhythmic drugs, or other drugs that could prolong the QT interval.
• Subjects receiving concurrent therapy with theophylline and who are eligible for recruitment, but the theophylline dose should be reduced by half during the time of concurrent use; and the serum levels of theophylline should be monitored at each visit as a guide to make some further adjustment in doses. Subjects with serum theophylline levels> 20 pg / mL while receiving concurrent therapy with the study drug should be withdrawn from the study.
• Subjects who have participated in a study with a research drug during the last 30 days,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method