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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00431678
First received: February 5, 2007
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Pneumonia
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Levofloxacin + Ceftriaxone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 748
Study Start Date: January 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431678

  Show 97 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00431678     History of Changes
Other Study ID Numbers: 11215
Study First Received: February 5, 2007
Last Updated: October 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Community-acquired Pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Levofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Renal Agents
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014