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

NCT ID: NCT00717561

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-06-30

Brief Summary

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.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Lungro, Cosenza, Italy

San Cesario di Lecce, Lecce, Italy

Fossombrone, Pesaro e Urbino, Italy

Pregiato Di Cava Dei Tirreni, Salerno, Italy

Vittorio Veneto, Treviso, Italy

Ascoli Piceno, , Italy

Benevento, , Italy

Brescia, , Italy

Catania, , Italy

Chieti, , Italy

Foggia, , Italy

Lucca, , Italy

Macerata, , Italy

Messina, , Italy

Milan, , Italy

Milan, , Italy

Palermo, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Sassari, , Italy

Torino, , Italy

Udine, , Italy

Countries

Italy

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for information provided by EMA

Other Identifiers

2007-001320-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12669

Identifier Type: -

Identifier Source: org_study_id