A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
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
2 other identifiers
interventional
60
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2008
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 4, 2014
October 1, 2014
1.2 years
July 16, 2008
November 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response 20 days after completion of study treatment (Test-of-Cure visit)
20 days after last dose of study drug (TOC Visit)
Secondary Outcomes (5)
Clinical and bacteriological response on the day of switch from IV to oral therapy
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)
Day 3-5
Bacteriological response at TOC
20 days after last dose of study drug
Clinical and bacteriological response at the end of treatment
Day 7-14 after first dose of study drug
Mortality attributable to pneumonia at the Test-of-Cure visit
20 days after last dose of study drug
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
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
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Lungro, Cosenza, 87010, Italy
Unknown Facility
San Cesario di Lecce, Lecce, 73016, Italy
Unknown Facility
Fossombrone, Pesaro e Urbino, 61034, Italy
Unknown Facility
Pregiato Di Cava Dei Tirreni, Salerno, 84013, Italy
Unknown Facility
Vittorio Veneto, Treviso, 31029, Italy
Unknown Facility
Ascoli Piceno, 63100, Italy
Unknown Facility
Benevento, 82100, Italy
Unknown Facility
Brescia, 25123, Italy
Unknown Facility
Catania, 95122, Italy
Unknown Facility
Chieti, 66100, Italy
Unknown Facility
Foggia, 71100, Italy
Unknown Facility
Lucca, 55100, Italy
Unknown Facility
Macerata, 62100, Italy
Unknown Facility
Messina, 98125, Italy
Unknown Facility
Milan, 20142, Italy
Unknown Facility
Milan, 20157, Italy
Unknown Facility
Palermo, 90146, Italy
Unknown Facility
Roma, 00135, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Roma, 00184, Italy
Unknown Facility
Sassari, 07100, Italy
Unknown Facility
Torino, 10154, Italy
Unknown Facility
Udine, 33100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 17, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
November 4, 2014
Record last verified: 2014-10