Pneumonia
Conditions
Keywords
CAP, Community-acquired pneumonia
Brief summary
The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.
Interventions
IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours
DRUGCeftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin
IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized non-ICU patients (age, \>= 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: * Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum * Dyspnea and/or tachypnea (respiratory rate of \> 20 breaths/min) * Rigors and/or chills * Pleuritic chest pain * Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation * Fever (an oral temperature of \>= 38 °C, a rectal temperature of \>= 39 °C, or a tympanic temperature of \>= 38.5 °C) or hypothermia (rectal or core temperature of \< 35 °C), and a WBC count of \>= 10,000 cells/mm3 or \>= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of \< 4500 cells/mm3) * Written informed consent
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response 20 days after completion of study treatment (Test-of-Cure visit) | 20 days after last dose of study drug (TOC Visit) |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and bacteriological response on the day of switch from IV to oral therapy | 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) | Day 3-5 |
| Bacteriological response at TOC | 20 days after last dose of study drug |
| Clinical and bacteriological response at the end of treatment | Day 7-14 after first dose of study drug |
| Mortality attributable to pneumonia at the Test-of-Cure visit | 20 days after last dose of study drug |
Countries
Italy
Outcome results
None listed