A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00717561
First received: July 16, 2008
Last updated: November 2, 2012
Last verified: November 2012
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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 3 |
| 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
Ceftriaxone
Ceftriaxone sodium
Clarithromycin
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
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.
|
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 | |
| Lungro, Cosenza, Italy, 87010 | |
| San Cesario, Lecce, Italy, 73016 | |
| Fossombrone, Pesaro e Urbino, Italy, 61034 | |
| Pregiato di Cava dei Tirreni, Salerno, Italy, 84013 | |
| Vittorio Veneto, Treviso, Italy, 31029 | |
| Ascoli Piceno, Italy, 63100 | |
| Benevento, Italy, 82100 | |
| Brescia, Italy, 25123 | |
| Catania, Italy, 95122 | |
| Chieti, Italy, 66100 | |
| Foggia, Italy, 71100 | |
| Lucca, Italy, 55100 | |
| Macerata, Italy, 62100 | |
| Messina, Italy, 98125 | |
| Milano, Italy, 20157 | |
| Milano, Italy, 20142 | |
| Palermo, Italy, 90146 | |
| Roma, Italy, 00168 | |
| Roma, Italy, 00135 | |
| Roma, Italy, 00184 | |
| Sassari, Italy, 07100 | |
| Torino, Italy, 10154 | |
| Udine, Italy, 33100 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer S.p.A. |
| ClinicalTrials.gov Identifier: | NCT00717561 History of Changes |
| Other Study ID Numbers: | 12669, 2007-001320-12 |
| Study First Received: | July 16, 2008 |
| Last Updated: | November 2, 2012 |
| 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 May 23, 2013