Trial Condition(s):

Pneumonia

A study to assess the efficacy and safety of IV/PO moxifloxacin in subjects with community-acquired pneumonia

Bayer Identifier:

12669

ClinicalTrials.gov Identifier:

NCT00717561

EudraCT Number:

2007-001320-12

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
60
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

AUSL 02 Lucca - Toscana

Lucca, Italy, 55100

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AUSL 2 Lanciano-Vasto-Chieti - Abruzzo

Chieti, Italy, 66100

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ASL Prov Cosenza - Calabria

Lungro, Italy, 87010

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A.C.O. San Filippo Neri

Roma, Italy, 00135

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ASL Salerno - Campania

Pregiato di Cava dei Tirreni, Italy, 84013

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A.O.U. di Sassari

Sassari, Italy, 07100

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A.O.U. Policlinico Martino

Messina, Italy, 98125

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A.O.C.O. S.Giovanni Addolorata

Roma, Italy, 00184

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ARNAS Garibaldi

Catania, Italy, 95122

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A.O. Spedali Civili

Brescia, Italy, 25123

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ASUR Marche ZT13 Ascoli Piceno

Ascoli Piceno, Italy, 63100

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A.O. Sacco Polo Universitario

Milano, Italy, 20157

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ASUR Marche ZT09 Macerata

Macerata, Italy, 62100

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AULSS 07 Pieve Soligo - Veneto

Vittorio Veneto, Italy, 31029

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AUSL Lecce - Puglia

San Cesario, Italy, 73016

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ASL TO/2 - Piemonte

Torino, Italy, 10154

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A.O. San Paolo Polo Universitario

Milano, Italy, 20142

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A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

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A.O. Vincenzo Cervello

Palermo, Italy, 90146

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A.O. Gaetano Rummo

Benevento, Italy, 82100

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Università Cattolica del Sacro Cuore

Roma, Italy, 00168

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A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

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ASUR Marche ZT01-02 Pesaro-Urb

Fossombrone, Italy, 61034

Trial Design