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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00717561

Purpose

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.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Ceftriaxone Ceftriaxone Sodium Clarithromycin Azithromycin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical and bacteriological response on the day of switch from IV to oral therapy [ Time Frame: Day of switch from IV to oral therapy ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Bacteriological response at TOC [ Time Frame: 20 days after last dose of study drug ] [ Designated as safety issue: No ]
Clinical and bacteriological response at the end of treatment [ Time Frame: Day 7-14 after first dose of study drug ] [ Designated as safety issue: No ]
Mortality attributable to pneumonia at the Test-of-Cure visit [ Time Frame: 20 days after last dose of study drug ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	February 2008
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 n/a	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
Active Comparator: Arm 2 n/a	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.

Arms

Assigned Interventions

Experimental: Arm 1

n/a

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

Active Comparator: Arm 2

n/a

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717561

Locations

Italy

Pesaro, Pesaro e Urbino, Italy, 61100

Nocera Inferiore, Salerno, Italy, 84014

Pieve di Soligo, Treviso, Italy, 31053

Ascoli Piceno, Italy, 63100

Benevento, Italy, 82100

Brescia, Italy, 25123

Catania, Italy, 95124

Chieti, Italy, 66100

Cosenza, Italy, 87100

Foggia, Italy, 71100

Lecce, Italy, 73100

Lucca, Italy, 55100

Macerata, Italy, 62100

Messina, Italy, 98125

Milano, Italy, 20157

Milano, Italy, 20142

Palermo, Italy, 90146

Roma, Italy, 00184

Roma, Italy, 00168

Roma, Italy, 00135

Sassari, Italy, 07100

Torino, Italy, 10149

Udine, Italy, 33100

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer S.p.A.
ClinicalTrials.gov Identifier:	NCT00717561 History of Changes
Other Study ID Numbers:	12669, EudraCT: 2007-001320-12
Study First Received:	July 16, 2008
Last Updated:	July 16, 2010
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Bayer:

CAP
Community-acquired pneumonia

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Ceftriaxone
Azithromycin
Amoxicillin-Potassium Clavulanate Combination
Clarithromycin
Clavulanic Acids
Clavulanic Acid
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012