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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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.

Clinical Details

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

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

Primary outcome: Clinical response 20 days after completion of study treatment (Test-of-Cure visit)

Secondary outcome:

Clinical and bacteriological response on the 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)

Bacteriological response at TOC

Clinical and bacteriological response at the end of treatment

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Ascoli Piceno 63100, Italy

Benevento 82100, Italy

Brescia 25123, Italy

Catania 95122, Italy

Chieti 66100, Italy

Foggia 71100, Italy

Lucca 55100, Italy

Macerata 62100, Italy

Messina 98125, Italy

Milano 20142, Italy

Milano 20157, Italy

Palermo 90146, Italy

Roma 00184, Italy

Roma 00168, Italy

Roma 00135, Italy

Sassari 07100, Italy

Torino 10154, Italy

Udine 33100, Italy

Lungro, Cosenza 87010, Italy

San Cesario, Lecce 73016, Italy

Fossombrone, Pesaro e Urbino 61034, Italy

Pregiato di Cava dei Tirreni, Salerno 84013, Italy

Vittorio Veneto, Treviso 31029, Italy

Additional Information

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 to find results for studies related to Bayer Healthcare products.

Click here and search for information provided by EMA

Starting date: February 2008
Last updated: November 2, 2014

Page last updated: August 23, 2015

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