A national, prospective, randomized, open label study to asses the efficacy and safety of IV/PO moxifloxacin vs IV ceftriaxone + IV azithromicin followed by PO amoxicilline/clavulanate and PO claritromycin in subjects with community-acquired pneumonia - ND

• Conditions: community-acquired pneumonia; MedDRA version: 6.1Level: HLGTClassification code 10024970

• Registration Number: EUCTR2007-001320-12-IT
• Lead Sponsor: BAYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Hospitalized non-ICU patients (age, > o equal 18 years) - clinical signs and symptoms of CAP, with PSI score IV or V - radiologically confirmed evidence of a new and/or progressive infiltrate(s) - requirement for initial parenteral therapy, - at least 2 of the following conditions: o productive or non productive cough with or without purulent or mucosus or mucopurulent sputum, o dyspnea and/or tachypnea (respiratory rate of > 20 breaths/min) o rigors and/or chills o pleuritic chest pain, o auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation, o fever (an oral temperature of > o equal 38 C, a rectal temperature of > o equal 39 C, or a tympanic temperature of > o equal 38.5 C) or hypothermia (rectal or core temperature of < 35 C), and a WBC count of > o equal 10,000 cells/mm3 or > o equal 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of <4500 cells/mm3). - Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- PSI Class I-III and V with need for ICU admission, - Hospitalization for > 48 hours before developing pneumonia, or discharge from hospital < 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study. - end-organ damage or shock (systolic blood pressure of <90 mm Hg and diastolic blood pressure of <60 mm Hg) with need for vasopressors for > 4 h, - need for mechanical ventilation, - implanted cardiac defibrillator, - clinically relevant bradycardia (heart rate of <50 beats/min), - mechanical endobronchial obstruction, - neutropenia (neutrophil count of <1000 neutrophils/mL), - chronic therapy (duration of > o equal 2 weeks) with immunosuppressant therapy (15 mg/day of systemic prednisone or equivalent), - renal impairment (serum creatinine clearance rate of <20 mL/min), - uncorrected hypokalemia, - Known hypersensitivity to fluoroquinolones, or other quinolones, and/or to beta-lactams, and/or macrolides or any of the excipients. - Female patients who are pregnant or lactating. Note: a urine pregnancy test will be performed in all women of childbearing potential prior to the administration of study medications. It will be confirmed by a serum pregnancy test. Patients can start on study therapy before results of the serum test are available. - History of tendon disease/disorder related to quinolone treatment. - Known congenital or documented-acquired QT prolongation; concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (eg, quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (eg, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (eg, phenthiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil); - clinically relevant heart failure with reduced left-ventricular ejection fraction; - previous history of symptomatic arrhythmias. - History of epilepsy. - Known defect in glucose-6-phosphate dehydrogenase - Known severe impaired liver function (ie, Child Pugh classification of C), (refer to Section 10.4 for definition) or transaminases increase > 5 fold ULN. - Systemic antibacterial therapy for more than 24 hours within 7 days prior to enrolment. Note: patients failing previous antimicrobial therapy which they have received for at least 48 hours for their current pneumonia episode can be enrolled, unless the antibacterial regimen contained a respiratory fluoroquinolone or a 3rd generation cephalosporin. - Patients requiring concomitant systemic antibacterial agents. - Known structural lung disease (eg., cystic fibrosis, bronchiectasis, or lung cancer), or other known conditions (eg., malnutrition) predisposing to infection with nosocomial-like organisms such as Pseudomonas aeruginosa. - Lung abscess, pleural empyema, risk factors for aspiration pneumonia (eg, recent stroke, head injury, dementia). - Known rapidly fatal underlying disease (death expected within 6 months). - Known or suspected active tuberculosis or endemic fungal infection. - Neutropenia (neutrophil count < 1,000/microL) caused by immunosuppressive therapy or malignancy. - Patients known to have AIDS (CD4 count < 200/microL) or HIV-seropositive who is r

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified