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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • 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, 00135
  • Roma, Italy, 00168
  • Roma, Italy, 00184
  • Sassari, Italy, 07100
  • Torino, Italy, 10154
  • Udine, Italy, 33100
  • Cosenza
    • Lungro, Cosenza, Italy, 87010
  • Lecce
    • San Cesario, Lecce, Italy, 73016
  • Pesaro e Urbino
    • Fossombrone, Pesaro e Urbino, Italy, 61034
  • Salerno
    • Pregiato di Cava dei Tirreni, Salerno, Italy, 84013
  • Treviso
    • Vittorio Veneto, Treviso, Italy, 31029

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	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.
Experimental: Arm 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical response 20 days after completion of study treatment (Test-of-Cure visit)	20 days after last dose of study drug (TOC Visit)

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical and bacteriological response on the day of switch from IV to oral therapy	Day of switch from IV to oral therapy
Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)	Day 3-5
Bacteriological response at TOC	20 days after last dose of study drug
Clinical and bacteriological response at the end of treatment	Day 7-14 after first dose of study drug
Mortality attributable to pneumonia at the Test-of-Cure visit	20 days after last dose of study drug

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here and search for information provided by EMA

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): November 4, 2014
• Last Update Submitted That Met QC Criteria: November 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: CAP; Community-acquired pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; beta-Lactamase Inhibitors; Moxifloxacin; Ceftriaxone; Norgestimate, ethinyl estradiol drug combination; Amoxicillin; Clarithromycin; Azithromycin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: 12669; 2007-001320-12 (EudraCT Number)