A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

Condition(s) targeted: Pneumonia

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical response 20 days after completion of study treatment (Test-of-Cure visit)

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Milano 20157, Italy; Not yet recruiting

Macerata 62100, Italy; Not yet recruiting

Lecce 73100, Italy; Not yet recruiting

Lucca 55100, Italy; Recruiting

Chieti 66100, Italy; Recruiting

Torino 10149, Italy; Recruiting

Cosenza 87100, Italy; Not yet recruiting

Milano 20142, Italy; Recruiting

Roma 00135, Italy; Not yet recruiting

Foggia 71100, Italy; Not yet recruiting

Sassari 07100, Italy; Not yet recruiting

Messina 98125, Italy; Not yet recruiting

Palermo 90146, Italy; Not yet recruiting

Benevento 82100, Italy; Recruiting

Roma 00184, Italy; Not yet recruiting

Roma 00168, Italy; Not yet recruiting

Udine 33100, Italy; Not yet recruiting

Catania 95124, Italy; Not yet recruiting

Brescia 25123, Italy; Not yet recruiting

Ascoli Piceno 63100, Italy; Recruiting

Pesaro, Pesaro e Urbino 61100, Italy; Not yet recruiting

Nocera Inferiore, Salerno 84014, Italy; Not yet recruiting

Pieve di Soligo, Treviso 31053, Italy; Not yet recruiting

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Starting date: February 2008
Ending date: February 2010
Last updated: September 15, 2009