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Completed

NCT Number: NCT00717561

A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin 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.

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Key information

Conditions

Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lungro, Cosenza, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avelox (Moxifloxacin, BAY12-8039)

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

Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Clinical and bacteriological response on the day of switch from IV to oral therapy

    Time frame: Day of switch from IV to oral therapy

  2. 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

  3. Bacteriological response at TOC

    Time frame: 20 days after last dose of study drug

  4. Clinical and bacteriological response at the end of treatment

    Time frame: Day 7-14 after first dose of study drug

  5. Mortality attributable to pneumonia at the Test-of-Cure visit

    Time frame: 20 days after last dose of study drug

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 17, 2008
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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