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

Bayer

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717561

2007-001320-12 (EudraCT Number)

12669

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Avelox (Moxifloxacin, BAY12-8039)

Arm 2

Active Comparator group

Treatment:

Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin