check_circleStudy Completed
Pneumonia
Bayer Identifier:
12669
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to assess the efficacy and safety of IV/PO moxifloxacin in subjects with community-acquired pneumonia
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
60Trial Dates
February 2008 - June 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | AUSL 02 Lucca - Toscana | Lucca, 55100, Italy |
Completed | AUSL 2 Lanciano-Vasto-Chieti - Abruzzo | Chieti, 66100, Italy |
Terminated | ASL Prov Cosenza - Calabria | Lungro, 87010, Italy |
Terminated | A.C.O. San Filippo Neri | Roma, 00135, Italy |
Terminated | ASL Salerno - Campania | Pregiato di Cava dei Tirreni, 84013, Italy |
Terminated | A.O.U. di Sassari | Sassari, 07100, Italy |
Terminated | A.O.U. Policlinico Martino | Messina, 98125, Italy |
Terminated | A.O.C.O. S.Giovanni Addolorata | Roma, 00184, Italy |
Terminated | ARNAS Garibaldi | Catania, 95122, Italy |
Terminated | A.O. Spedali Civili | Brescia, 25123, Italy |
Completed | ASUR Marche ZT13 Ascoli Piceno | Ascoli Piceno, 63100, Italy |
Completed | A.O. Sacco Polo Universitario | Milano, 20157, Italy |
Completed | ASUR Marche ZT09 Macerata | Macerata, 62100, Italy |
Terminated | AULSS 07 Pieve Soligo - Veneto | Vittorio Veneto, 31029, Italy |
Terminated | AUSL Lecce - Puglia | San Cesario, 73016, Italy |
Completed | ASL TO/2 - Piemonte | Torino, 10154, Italy |
Completed | A.O. San Paolo Polo Universitario | Milano, 20142, Italy |
Terminated | A.O.U. Ospedali Riuniti Foggia | Foggia, 71100, Italy |
Terminated | A.O. Vincenzo Cervello | Palermo, 90146, Italy |
Completed | A.O. Gaetano Rummo | Benevento, 82100, Italy |
Completed | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Terminated | A.O.U. Santa Maria Misericordia UD | Udine, 33100, Italy |
Completed | ASUR Marche ZT01-02 Pesaro-Urb | Fossombrone, 61034, Italy |
Primary Outcome
- Clinical response 20 days after completion of study treatment (Test-of-Cure visit)date_rangeTime Frame:20 days after last dose of study drug (TOC Visit)enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Clinical and bacteriological response on the day of switch from IV to oral therapydate_rangeTime Frame:Day of switch from IV to oral therapyenhanced_encryptionnoSafety Issue:
- Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)date_rangeTime Frame:Day 3-5enhanced_encryptionnoSafety Issue:
- Bacteriological response at TOCdate_rangeTime Frame:20 days after last dose of study drugenhanced_encryptionnoSafety Issue:
- Clinical and bacteriological response at the end of treatmentdate_rangeTime Frame:Day 7-14 after first dose of study drugenhanced_encryptionnoSafety Issue:
- Mortality attributable to pneumonia at the Test-of-Cure visitdate_rangeTime Frame:20 days after last dose of study drugenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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