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

December 16, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

738

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Vicente López, Buenos Aires, Argentina, B1602DOH
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1118AAT
      • Buenos Aires, Capital Federal, Argentina, C1120AAF
      • Buenos Aires, Capital Federal, Argentina, C1180AAX
      • Buenos Aires, Capital Federal, Argentina, C1431FWO
  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1200
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
      • Namur, Belgium, 5000
  • Chile
      • Santiago, Chile
      • Santiago de Chile, Chile
    • IX Region
      • Temuco, IX Region, Chile
    • V Region
      • Viña del Mar, V Region, Chile
  • Colombia
      • Bogotá, Colombia
      • Bucaramanga, Colombia
      • Santafé de Bogotá, Colombia
  • France
      • Agen, France, 47923
      • Aix-en-provence, France, 13616
      • Argenteuil, France, 95107
      • Avignon, France, 84000
      • Belfort, France, 90016
      • Bordeaux, France, 33000
      • Brive-la-gaillarde, France, 19100
      • Paris, France, 75014
      • Saint-gaudens, France, 31806
      • Toulon, France, 83056
      • Vesoul, France, 70014
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 13353
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44789
      • Bochum, Nordrhein-Westfalen, Germany, 44791
      • Lüdenscheid, Nordrhein-Westfalen, Germany, 58515
      • Paderborn, Nordrhein-Westfalen, Germany, 33098
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06112
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
  • Greece
      • Athens, Greece, 11527
      • Thessaloniki, Greece, 546 36
    • Patras
      • Rio, Patras, Greece, 265 04
  • Israel
      • Afula, Israel, 18101
      • Ashkelon, Israel, 78306
      • Holon, Israel, 58100
      • Tel Aviv, Israel, 64239
      • Tel Hashomer, Israel, 52621
  • Lithuania
      • Kaunas, Lithuania, 45130
      • Kaunas, Lithuania, 47144
      • Vilnius, Lithuania, LT-2001
      • Vilnius, Lithuania, LT-2006
  • Mexico
      • México, D.F., Mexico, 02290
      • México, D.F., Mexico, 07760
      • México, D.F., Mexico, 14000
      • México, D.F., Mexico, 14080
    • Edo. de México
      • Toluca, Edo. de México, Mexico, 50130
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
  • Netherlands
      • Den Bosch, Netherlands, 5211 RB
      • EDE, Netherlands, 6716 RP
      • Harderwijk, Netherlands, 3844 DG
      • Heerlen, Netherlands, 6419 PC
    • Noord Brabant
      • Eindhoven, Noord Brabant, Netherlands, 5623 EJ
  • Peru
      • Callao, Peru, 02
      • Lima, Peru, 01
      • Lima Cercado, Peru, LIMA 1
  • Poland
      • Bydgoszcz, Poland, 85-326
      • Gdansk, Poland, 80-803
      • Krakow, Poland, 30-501
      • Lodz, Poland, 91-425
      • Warszawa, Poland, 01-138
      • Warszawa, Poland, 00-909
      • Wroclaw, Poland, 50-417
  • Portugal
      • Lisboa, Portugal, 1769-001
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9300
    • Gauteng
      • Brits, Gauteng, South Africa, 0250
      • Johannesburg, Gauteng, South Africa, 2132
      • Pretoria, Gauteng, South Africa, 0083
    • Western Cape
      • Cape Town, Western Cape, South Africa
      • Somerset West, Western Cape, South Africa, 7130
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Guadalajara, Spain, 19002
      • Madrid, Spain, 28008
      • Valencia, Spain, 46014
    • Aragón
      • Huesca, Aragón, Spain, 22004
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805
  • Sweden
      • Jönköping, Sweden, 551 85
      • Kalmar, Sweden, 391 85
      • Karlstad, Sweden, 651 85
      • Skövde, Sweden, 541 85
  • United Kingdom
    • Cleveland
      • Middlesborough, Cleveland, United Kingdom, TS4 3BW
    • Dumfries and Galloway
      • Dumfries, Dumfries and Galloway, United Kingdom, DG1 4EP
    • Humberside
      • Hull, Humberside, United Kingdom, HU3 2JZ
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH4 2XU
    • South Yorkshire
      • Rotherham, South Yorkshire, United Kingdom, S60 2UD
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response
Time Frame: 5 to 7 days after last dose of study medication
5 to 7 days after last dose of study medication

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11215 (REGISTRY: DAIDS ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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