community-acquired pneumonia MedDRA version: 6.1 Level: HLGT Classification code 10024970
Conditions
Interventions
Trade Name: AVALOX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Moxifloxacin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Trade Name: Moxif
Sponsors
BAYER
Eligibility
Sex/Gender
All
Inclusion criteria
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 o equal 10,000 cells/mm3 or > o equal 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - PSI Class I-III and V with need for ICU admission, - Hospitalization for > 48 hours before developing pneumonia, or discharge from hospital 4 h, - need for mechanical ventilation, - implanted cardiac defibrillator, - clinically relevant bradycardia (heart rate of o equal 2 weeks) with immunosuppressant therapy (15 mg/day of systemic prednisone or equivalent), - renal impairment (serum creatinine clearance rate of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To estimate the clinical answer to final visit (TOC);Main Objective: To assess the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy in comparison to a combination therapy with intravenous ceftriaxone plus azithromicin followed by oral amoxicillin/clavulanic acid and claritromycin, in patients with CAP. The primary aim of the study will be to prove the hypothesis that therapy with moxifloxacin IV/PO 400/400 mg once daily is not less effective than the control therapy based on clinical cure rate at the Test-of-Cure visit.;Secondary Objective: Clinical and bacteriological response on the day of switch from IV to oral therapy. Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5). Bacteriological response at TOC Clinical and bacteriological response at the end of treatment. Mortality attributable to pneumonia at the Test-of-Cure visit. CAP-symptoms course (at the different assessment visits). An economic analysis will be performed to assess the implications of each treatment arm on healthcare resource utilization and on overall costs associated with the treatment of CAP. All patients receiving at least one dose of study drug will be included in the safety analysis. | — |
Countries
Italy
Outcome results
None listed