Status:
COMPLETED
A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
Lead Sponsor:
Bayer
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 amoxici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00717561
Start Date
February 1 2008
End Date
June 1 2009
Last Update
November 4 2014
Active Locations (23)
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1
Lungro, Cosenza, Italy, 87010
2
San Cesario di Lecce, Lecce, Italy, 73016
3
Fossombrone, Pesaro e Urbino, Italy, 61034
4
Pregiato Di Cava Dei Tirreni, Salerno, Italy, 84013