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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717561
• Other study ID #: 12669
• Secondary ID: 2007-001320-12
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2008
• Last updated: November 2, 2014
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response 20 days after completion of study treatment (Test-of-Cure visit)		20 days after last dose of study drug (TOC Visit)	No
Secondary	Clinical and bacteriological response on the day of switch from IV to oral therapy		Day of switch from IV to oral therapy	No
Secondary	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	No
Secondary	Bacteriological response at TOC		20 days after last dose of study drug	No
Secondary	Clinical and bacteriological response at the end of treatment		Day 7-14 after first dose of study drug	No
Secondary	Mortality attributable to pneumonia at the Test-of-Cure visit		20 days after last dose of study drug	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for information provided by EMA
•   Click here to find results for studies related to Bayer Healthcare products.