Trial Condition(s):
A study to assess the efficacy and safety of IV/PO moxifloxacin in subjects with community-acquired pneumonia
12669
Not Available
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.
- 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
- 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 | |
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Locations AUSL 02 Lucca - Toscana Lucca, Italy, 55100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 2 Lanciano-Vasto-Chieti - Abruzzo Chieti, Italy, 66100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL Prov Cosenza - Calabria Lungro, Italy, 87010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.C.O. San Filippo Neri Roma, Italy, 00135 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL Salerno - Campania Pregiato di Cava dei Tirreni, Italy, 84013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Sassari Sassari, Italy, 07100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Martino Messina, Italy, 98125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.C.O. S.Giovanni Addolorata Roma, Italy, 00184 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ARNAS Garibaldi Catania, Italy, 95122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT13 Ascoli Piceno Ascoli Piceno, Italy, 63100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sacco Polo Universitario Milano, Italy, 20157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT09 Macerata Macerata, Italy, 62100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 07 Pieve Soligo - Veneto Vittorio Veneto, Italy, 31029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Lecce - Puglia San Cesario, Italy, 73016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL TO/2 - Piemonte Torino, Italy, 10154 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Paolo Polo Universitario Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Foggia Foggia, Italy, 71100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Vincenzo Cervello Palermo, Italy, 90146 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Gaetano Rummo Benevento, Italy, 82100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT01-02 Pesaro-Urb Fossombrone, Italy, 61034 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2