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

NCT00431678 | Completed Phase 3

• 1 other identifier: 11215
• Study Type: interventional
• Target: 738
• Locations: 18 countries
• Sites: 95

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.

Conditions

Pneumonia

Keywords

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Clinical response

  5 to 7 days after last dose of study medication

Secondary Outcomes (8)

• Clinical and bacteriological response

  At the day of switch from intravenous to oral therapy

• Clinical and bacteriological response on treatment

  At day 3 to 5

• Clinical and bacteriological response

  At the end of treatment

• Bacteriological response

  5-7 days after end of treatment

• Mortality attributable to pneumonia

  5-7 days after end of treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Arm 2

ACTIVE COMPARATOR

Drug: Levofloxacin + Ceftriaxone

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)

Arm 1

Levofloxacin + Ceftriaxone DRUG

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).

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (95)

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Vicente López, Buenos Aires, B1602DOH, Argentina

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Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

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Buenos Aires, Buenos Aires F.D., C1120AAF, Argentina

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Buenos Aires, Buenos Aires F.D., C1180AAX, Argentina

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Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina

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Bruxelles - Brussel, 1070, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Namur, 5000, Belgium

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Temuco, Región de la Araucanía, Chile

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Chile

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Bogotá, Colombia

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Bucaramanga, Colombia

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Agen, 47923, France

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Aix-en-Provence, 13616, France

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Argenteuil, 95107, France

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Avignon, 84000, France

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Belfort, 90016, France

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Bordeaux, 33000, France

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Brive-la-Gaillarde, 19100, France

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Paris, 75014, France

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Saint-Gaudens, 31806, France

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Toulon, 83056, France

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Vesoul, 70014, France

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Bochum, North Rhine-Westphalia, 44789, Germany

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Bochum, North Rhine-Westphalia, 44791, Germany

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Lüdenscheid, North Rhine-Westphalia, 58515, Germany

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Paderborn, North Rhine-Westphalia, 33098, Germany

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Halle, Saxony-Anhalt, 06112, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Berlin, State of Berlin, 10117, Germany

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Berlin, State of Berlin, 13353, Germany

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Rio, Patras, 265 04, Greece

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Thessaloniki, Thessaloniki, 546 36, Greece

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Athens, 11527, Greece

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Afula, Israel, 18101, Israel

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Ashkelon, Israel, 78306, Israel

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Holon, Israel, 58100, Israel

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Tel Aviv, Israel, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Kaunas, 45130, Lithuania

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Kaunas, 47144, Lithuania

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Vilnius, LT-2001, Lithuania

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Vilnius, LT-2006, Lithuania

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Toluca, Edo. de México, 50130, Mexico

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Guadalajara, Jalisco, 44280, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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México, D.F., 02290, Mexico

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México, D.F., 07760, Mexico

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México, D.F., 14000, Mexico

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México, D.F., 14080, Mexico

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Eindhoven, North Brabant, 5623 EJ, Netherlands

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's-Hertogenbosch, 5211 RB, Netherlands

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Ede, 6716 RP, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Heerlen, 6419 PC, Netherlands

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Callao, 02, Peru

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Lima, 01, Peru

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Lima Cercado, LIMA 1, Peru

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Bydgoszcz, 85-326, Poland

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Gdansk, 80-803, Poland

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Krakow, 30-501, Poland

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Lodz, 91-425, Poland

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Warsaw, 00-909, Poland

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Warsaw, 01-138, Poland

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Wroclaw, 50-417, Poland

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Lisbon, 1769-001, Portugal

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Bloemfontein, Free State, South Africa

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Bloemfontein, Freestate, 9300, South Africa

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Brits, Gauteng, 0250, South Africa

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Johannesburg, Gauteng, 2132, South Africa

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Pretoria, Gauteng, 0083, South Africa

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Cape Town, Western Cape, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Huesca, Aragon, 22004, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08036, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Guadalajara, Guadalajara, 19002, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Madrid, Madrid, 28008, Spain

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Valencia, Valencia, 46014, Spain

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Jönköping, 551 85, Sweden

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Kalmar, 391 85, Sweden

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Karlstad, 651 85, Sweden

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Skövde, 541 85, Sweden

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Middlesbrough, Cleveland, TS4 3BW, United Kingdom

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Dumfries, Dumfries and Galloway, DG1 4EP, United Kingdom

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Hull, Humberside, HU3 2JZ, United Kingdom

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Edinburgh, Lothian, EH4 2XU, United Kingdom

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Rotherham, South Yorkshire, S60 2UD, United Kingdom

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Sheffield, South Yorkshire, S10 2JF, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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Related Publications (1)

• 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.

  PMID: 18419482 DERIVED

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Interventions

Moxifloxacin; Levofloxacin; Ceftriaxone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 6, 2007
• Study Start: January 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

ZA (7); PT (1); BE (5); DE (8); GB (7); PE (3); AR (5); IL (5); FR (11); NL (5); PL (7); CO (2); LI (4); ES (8); ME (7); GR (3); SE (4); CL (3)