Pneumonia Clinical Trial
Official title:
A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia
Verified date | October 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response 20 days after completion of study treatment (Test-of-Cure visit) | 20 days after last dose of study drug (TOC Visit) | No | |
Secondary | Clinical and bacteriological response on the day of switch from IV to oral therapy | Day of switch from IV to oral therapy | No | |
Secondary | 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 | No | |
Secondary | Bacteriological response at TOC | 20 days after last dose of study drug | No | |
Secondary | Clinical and bacteriological response at the end of treatment | Day 7-14 after first dose of study drug | No | |
Secondary | Mortality attributable to pneumonia at the Test-of-Cure visit | 20 days after last dose of study drug | No |
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