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Efficacy and Safety of Sequential IV/PO Moxifloxacin in Comparison to IV Levofloxacin Plus IV Ceftriaxone Followed by PO Levofloxacin, in the Treatment of Patients With Community-acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431678
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):

Brief Summary:
Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin + Ceftriaxone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multinational, Prospective, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Sequential Intravenous/Oral Moxifloxacin in Comparison to Intravenous Levofloxacin Plus Intravenous Ceftriaxone Followed by Oral Levofloxacin, in the Treatment of Patients With Severe Community-acquired Pneumonia
Study Start Date : January 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Arm Intervention/treatment
Experimental: Arm 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)

Active Comparator: Arm 2 Drug: Levofloxacin + Ceftriaxone
Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).

Primary Outcome Measures :
  1. Clinical response [ Time Frame: 5 to 7 days after last dose of study medication ]

Secondary Outcome Measures :
  1. Clinical and bacteriological response [ Time Frame: At the day of switch from intravenous to oral therapy ]
  2. Clinical and bacteriological response on treatment [ Time Frame: At day 3 to 5 ]
  3. Clinical and bacteriological response [ Time Frame: At the end of treatment ]
  4. Bacteriological response [ Time Frame: 5-7 days after end of treatment ]
  5. Mortality attributable to pneumonia [ Time Frame: 5-7 days after end of treatment ]
  6. Clinical and bacteriological response [ Time Frame: At days 21 to 28 after end of treatment ]
  7. Symptoms course of community-acquired pneumonia [ Time Frame: at defined visits ]
  8. Adverse Event Collection [ Time Frame: all visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 years or above
  • All of the following signs and symptoms of pneumonia:

    • Fever (core/ rectal/ tympanic temperature >/= 38.5°C or axillary/ oral/ cutaneous temperature >/= 38.0°C) or hypothermia (core/ rectal/ tympanic temperature </= 35.5°C or axillary/ oral/ cutaneous temperature </= 35.0°C)
    • White blood cell (WBC) count > 10,000/µL, or >/= 15% immature neutrophils (bands), regardless of the peripheral WBC count, or total WBC count < 4,500/µL
    • The presence of at least 2 of the following symptoms: - Cough- Purulent sputum production
  • Dyspnoea or tachypnoea (respiratory rate > 20 breaths/minute)
  • Rigors and/or chills- Chest pain
  • Auscultatory findings on pulmonary examination of rales/crackles and/or evidence of pulmonary consolidationAND
  • Radiological evidence of (an) infiltrate(s) consistent with bacterial pneumonia at baseline or within 24 hours following enrolment
  • Fine score >/= 71 (i.e. Pneumonia PSI risk Class III, IV or V, requiring hospitalisation for the treatment of CAP)
  • Written informed consent obtained from the patient or a next-of-kin

Exclusion Criteria:

  • Known hypersensitivity to fluoroquinolones, or other quinolones, and/or to beta-lactams, or any of the excipients
  • Female patients who are pregnant or lactating
  • History of tendon disease/disorder related to quinolone treatment
  • Known congenital or documented-acquired QT prolongation; concomitant use of drugs, reported to increase the QT interval; uncorrected hypokalaemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left
  • ventricular ejection fraction; previous history of symptomatic arrhythmias
  • History of epilepsy- Known glucose-6-phosphate dehydrogenase deficiency
  • Known severe impaired liver function (i.e. Child Pugh C), (refer to Section 10.4 for definition) or transaminases increase > 5 fold ULN- Hospitalisation for > 48 hours before developing pneumonia, or discharge from hospital < 30 days prior- Systemic antibacterial therapy for more than 24 hours within 14 days of enrolment
  • Patients requiring concomitant systemic antibacterial agents
  • Known structural lung disease (e.g. cystic fibrosis, bronchiectasis, or lung cancer), or other known conditions (e.g. malnutrition) predisposing to infection with nosocomial-like organisms such as Pseudomonas aeruginosa
  • Lung abscess, pleural empyema, risk factors for aspiration pneumonia (e.g. recent stroke, head injury, dementia)
  • Known rapidly fatal underlying disease (death expected within 6 months)
  • Known or suspected active tuberculosis or endemic fungal infection- Neutropenia (neutrophil count < 1,000/µL) caused by immunosuppressive therapy or malignancy
  • Patients known to have AIDS (CD4 count < 200/µL) or HIV-seropositive patients receiving HAART
  • Previous enrolment in this study
  • Participation in any clinical investigational drug study within the previous 4 weeks
  • Patient with pre-terminal renal failure (creatinine clearance < 10 mL/min) and patients undergoing haemodialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431678

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00431678    
Other Study ID Numbers: 11215
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Community-acquired Pneumonia
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Anti-Infective Agents, Urinary
Renal Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors