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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

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ClinicalTrials.gov Identifier: NCT00431678
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 5, 2007
First Posted Date  ICMJE February 6, 2007
Last Update Posted Date December 17, 2014
Study Start Date  ICMJE January 2004
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Clinical response [ Time Frame: 5 to 7 days after last dose of study medication ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
  • Clinical and bacteriological response [ Time Frame: At the day of switch from intravenous to oral therapy ]
  • Clinical and bacteriological response on treatment [ Time Frame: At day 3 to 5 ]
  • Clinical and bacteriological response [ Time Frame: At the end of treatment ]
  • Bacteriological response [ Time Frame: 5-7 days after end of treatment ]
  • Mortality attributable to pneumonia [ Time Frame: 5-7 days after end of treatment ]
  • Clinical and bacteriological response [ Time Frame: At days 21 to 28 after end of treatment ]
  • Symptoms course of community-acquired pneumonia [ Time Frame: at defined visits ]
  • Adverse Event Collection [ Time Frame: all visits ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • Drug: Avelox (Moxifloxacin, BAY12-8039)
    Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
  • 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).
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Active Comparator: Arm 2
    Intervention: Drug: Levofloxacin + Ceftriaxone
Publications * Torres A, Garau J, Arvis P, Carlet J, Choudhri S, Kureishi A, Le Berre MA, Lode H, Winter J, Read RC; MOTIV (MOxifloxacin Treatment IV) Study Group. Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study--a randomized clinical trial. Clin Infect Dis. 2008 May 15;46(10):1499-509. doi: 10.1086/587519.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2014)
738
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Chile,   Colombia,   France,   Germany,   Greece,   Israel,   Lithuania,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   South Africa,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00431678
Other Study ID Numbers  ICMJE 11215
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP