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

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
Status
LocationsStatus
Locations

AUSL 02 Lucca - Toscana

Lucca, Italy, 55100

Status
Completed
 
Locations

AUSL 2 Lanciano-Vasto-Chieti - Abruzzo

Chieti, Italy, 66100

Status
Completed
 
Locations

ASL Prov Cosenza - Calabria

Lungro, Italy, 87010

Status
Terminated
 
Locations

A.C.O. San Filippo Neri

Roma, Italy, 00135

Status
Terminated
 
Locations

ASL Salerno - Campania

Pregiato di Cava dei Tirreni, Italy, 84013

Status
Terminated
 
Locations

A.O.U. di Sassari

Sassari, Italy, 07100

Status
Terminated
 
Locations

A.O.U. Policlinico Martino

Messina, Italy, 98125

Status
Terminated
 
Locations

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

Roma, Italy, 00184

Status
Terminated
 
Locations

ARNAS Garibaldi

Catania, Italy, 95122

Status
Terminated
 
Locations

A.O. Spedali Civili

Brescia, Italy, 25123

Status
Terminated
 
Locations

ASUR Marche ZT13 Ascoli Piceno

Ascoli Piceno, Italy, 63100

Status
Completed
 
Locations

A.O. Sacco Polo Universitario

Milano, Italy, 20157

Status
Completed
 
Locations

ASUR Marche ZT09 Macerata

Macerata, Italy, 62100

Status
Completed
 
Locations

AULSS 07 Pieve Soligo - Veneto

Vittorio Veneto, Italy, 31029

Status
Terminated
 
Locations

AUSL Lecce - Puglia

San Cesario, Italy, 73016

Status
Terminated
 
Locations

ASL TO/2 - Piemonte

Torino, Italy, 10154

Status
Completed
 
Locations

A.O. San Paolo Polo Universitario

Milano, Italy, 20142

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

Status
Terminated
 
Locations

A.O. Vincenzo Cervello

Palermo, Italy, 90146

Status
Terminated
 
Locations

A.O. Gaetano Rummo

Benevento, Italy, 82100

Status
Completed
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Terminated
 
Locations

ASUR Marche ZT01-02 Pesaro-Urb

Fossombrone, Italy, 61034

Status
Completed
 

Trial Design