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A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
This study is currently recruiting participants.
Verified by Bayer, September 2009
First Received: July 16, 2008   Last Updated: September 15, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00717561
  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.


Condition Intervention Phase
Pneumonia
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical response 20 days after completion of study treatment (Test-of-Cure visit) [ Time Frame: 20 days after last dose of study drug (TOC Visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and bacteriological response on the day of switch from IV to oral therapy [ Time Frame: Day of switch from IV to oral therapy ] [ Designated as 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) [ Time Frame: Day 3-5 ] [ Designated as safety issue: No ]
  • Bacteriological response at TOC [ Time Frame: 20 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical and bacteriological response at the end of treatment [ Time Frame: Day 7-14 after first dose of study drug ] [ Designated as safety issue: No ]
  • Mortality attributable to pneumonia at the Test-of-Cure visit [ Time Frame: 20 days after last dose of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental
n/a
Drug: Avelox (Moxifloxacin, BAY12-8039)
IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours
Arm 2: Active Comparator
n/a
Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.

Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717561

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Italy
Not yet recruiting
Milano, Italy, 20157
Not yet recruiting
Macerata, Italy, 62100
Not yet recruiting
Lecce, Italy, 73100
Recruiting
Lucca, Italy, 55100
Recruiting
Chieti, Italy, 66100
Not yet recruiting
Sassari, Italy, 07100
Not yet recruiting
Cosenza, Italy, 87100
Recruiting
Milano, Italy, 20142
Not yet recruiting
Roma, Italy, 00135
Not yet recruiting
Foggia, Italy, 71100
Recruiting
Torino, Italy, 10149
Not yet recruiting
Messina, Italy, 98125
Not yet recruiting
Palermo, Italy, 90146
Recruiting
Benevento, Italy, 82100
Not yet recruiting
Roma, Italy, 00184
Not yet recruiting
Roma, Italy, 00168
Not yet recruiting
Udine, Italy, 33100
Not yet recruiting
Catania, Italy, 95124
Not yet recruiting
Brescia, Italy, 25123
Recruiting
Ascoli Piceno, Italy, 63100
Italy, Pesaro e Urbino
Not yet recruiting
Pesaro, Pesaro e Urbino, Italy, 61100
Italy, Salerno
Not yet recruiting
Nocera Inferiore, Salerno, Italy, 84014
Italy, Treviso
Not yet recruiting
Pieve di Soligo, Treviso, Italy, 31053
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer S.p.A. ( Therapeutic Area Head )
Study ID Numbers: 12669, 2007-001320-12
Study First Received: July 16, 2008
Last Updated: September 15, 2009
ClinicalTrials.gov Identifier: NCT00717561     History of Changes
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Bayer:
CAP
Community-acquired pneumonia

Additional relevant MeSH terms:
Anti-Infective Agents
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Clavulanic Acids
Enzyme Inhibitors
Ceftriaxone
Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions
Protein Synthesis Inhibitors
Clarithromycin
Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Therapeutic Uses
Lung Diseases
Azithromycin
Clavulanic Acid
Pneumonia

ClinicalTrials.gov processed this record on February 08, 2010