A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00717561
First received: July 16, 2008
Last updated: October 28, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
Active Comparator: Arm 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Lungro, Cosenza, Italy, 87010
San Cesario, Lecce, Italy, 73016
Fossombrone, Pesaro e Urbino, Italy, 61034
Pregiato di Cava dei Tirreni, Salerno, Italy, 84013
Vittorio Veneto, Treviso, Italy, 31029
Ascoli Piceno, Italy, 63100
Benevento, Italy, 82100
Brescia, Italy, 25123
Catania, Italy, 95122
Chieti, Italy, 66100
Foggia, Italy, 71100
Lucca, Italy, 55100
Macerata, Italy, 62100
Messina, Italy, 98125
Milano, Italy, 20157
Milano, Italy, 20142
Palermo, Italy, 90146
Roma, Italy, 00168
Roma, Italy, 00135
Roma, Italy, 00184
Sassari, Italy, 07100
Torino, Italy, 10154
Udine, Italy, 33100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00717561     History of Changes
Other Study ID Numbers: 12669, 2007-001320-12
Study First Received: July 16, 2008
Last Updated: October 28, 2013
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Bayer:
CAP
Community-acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Ceftriaxone
Azithromycin
Amoxicillin-Potassium Clavulanate Combination
Clarithromycin
Clavulanic Acids
Clavulanic Acid
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014