check_circleStudy Completed

Pneumonia

Bayer Identifier:

12669

ClinicalTrials.gov Identifier:

NCT00717561

EudraCT Number:

2007-001320-12

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

Both

Age

18 Years
  • - 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

Trial summary

Enrollment Goal
60
Trial Dates
February 2008 - June 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
AUSL 02 Lucca - ToscanaLucca, 55100, Italy
Completed
AUSL 2 Lanciano-Vasto-Chieti - AbruzzoChieti, 66100, Italy
Terminated
ASL Prov Cosenza - CalabriaLungro, 87010, Italy
Terminated
A.C.O. San Filippo NeriRoma, 00135, Italy
Terminated
ASL Salerno - CampaniaPregiato di Cava dei Tirreni, 84013, Italy
Terminated
A.O.U. di SassariSassari, 07100, Italy
Terminated
A.O.U. Policlinico MartinoMessina, 98125, Italy
Terminated
A.O.C.O. S.Giovanni AddolorataRoma, 00184, Italy
Terminated
ARNAS GaribaldiCatania, 95122, Italy
Terminated
A.O. Spedali CiviliBrescia, 25123, Italy
Completed
ASUR Marche ZT13 Ascoli PicenoAscoli Piceno, 63100, Italy
Completed
A.O. Sacco Polo UniversitarioMilano, 20157, Italy
Completed
ASUR Marche ZT09 MacerataMacerata, 62100, Italy
Terminated
AULSS 07 Pieve Soligo - VenetoVittorio Veneto, 31029, Italy
Terminated
AUSL Lecce - PugliaSan Cesario, 73016, Italy
Completed
ASL TO/2 - PiemonteTorino, 10154, Italy
Completed
A.O. San Paolo Polo UniversitarioMilano, 20142, Italy
Terminated
A.O.U. Ospedali Riuniti FoggiaFoggia, 71100, Italy
Terminated
A.O. Vincenzo CervelloPalermo, 90146, Italy
Completed
A.O. Gaetano RummoBenevento, 82100, Italy
Completed
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Terminated
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Completed
ASUR Marche ZT01-02 Pesaro-UrbFossombrone, 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_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical and bacteriological response on the day of switch from IV to oral therapy
    date_rangeTime Frame:
    Day of switch from IV to oral therapy
    enhanced_encryption
    Safety Issue:
    no
  • 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 3-5
    enhanced_encryption
    Safety Issue:
    no
  • Bacteriological response at TOC
    date_rangeTime Frame:
    20 days after last dose of study drug
    enhanced_encryption
    Safety Issue:
    no
  • Clinical and bacteriological response at the end of treatment
    date_rangeTime Frame:
    Day 7-14 after first dose of study drug
    enhanced_encryption
    Safety Issue:
    no
  • Mortality attributable to pneumonia at the Test-of-Cure visit
    date_rangeTime Frame:
    20 days after last dose of study drug
    enhanced_encryption
    Safety Issue:
    no

Trial design

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

Additional Information

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