None listed
Conditions
Interventions
Grepafloxacin Type of group
Grepafloxacin in a dose of 600 mg orally once a day (1 tablet x 600 mg) with a concurrent placebo once a day (one capsule, similar in appearance to trovafloxacin in the 200 mg capsule) for 10 days.
Group name:Trovafloxacin Type of group
Trovafloxacin in a dose of 200 mg orally once a day (1 capsule x 200 mg) with a concurrent placebo once a day (one tablet, similar in appearance to grepafloxacin in the 600 mg tablet) for 10 days.
Sponsors
GLAXO WELCOME S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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 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 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:At each visit in the study the investigator will evaluate the following signs and symptoms of pneumonia (the intensity will be evaluated subjectively as: absent, mild, moderate or severe): • Cough. • Dyspnea. • Pleuritic chest pain. • Shaking chills. The following shall be recorded as present or absent: • Added noises. • Maturity in percussion. • Pleural rub. • Arthralgia. • Myalgia. Clinical cure: The clinical signs and symptoms of pneumonia have improved or resolved at the visit at 1-3 days after treatment and are absent at the visit at 28-35 days after treatment. Clinical improvement: There is improvement, but an incomplete resolution of clinical signs and symptoms of pneumonia in the visit at 28-35 days after treatment, no additional antibiotic treatment is indicated. Clinical failure: There is no apparent improvement in the symptoms and clinical signs of pneumonia in response to therapy during visits during or 1-3 days after treatment; or the drug was discontinued due to the occurrence of an adverse event related to it. Clinical recurrence: Resolution or improvement of the clinical signs and symptoms of pneumonia in the visit at 1-3 days after treatment, with recurrence of clinical symptoms at 28-35 days after treatment. Measure:Efficacy Timepoints:Improvement of symptoms in 1-3 days after treatment and absence of these at the visit at 28-35 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The satisfaction of the subjects with the treatment will be recorded in Visits 2 and 3. The subjects will be asked if they are very satisfied, moderately satisfied, little satisfied, or satisfied or dissatisfied, a little dissatisfied, moderately dissatisfied or very dissatisfied. Measure:Patient Satisfaction Timepoints:Druing visits 2 and 3 ; Outcome name:The radiological response for ALL subjects will be qualified and registered in the FRC, as follows in the final evaluation of the study (Visit 4): It was resolved: the areas of infiltration or consolidation are completely clear. Improved: areas of infiltration or consolidation still exist, but show evidence of clarification. No changes / worse; the areas of infiltration or consolidation do not show changes. OR the areas of infiltration or consolidation show evidence of increase in area or increase its density. Measure:Radiological Response Timepoints:During visit 4 | — |
Outcome results
None listed