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

Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

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

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.

Clinical Details

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

Eligibility

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

Locations and Contacts

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

Additional Information

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products

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

Page last updated: October 19, 2009

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