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PneumoniaPhase 3NCT00431678

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

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Levofloxacin + Ceftriaxone in people with Pneumonia, run by Bayer at 95 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia
What is being tested?
Avelox (Moxifloxacin, BAY12-8039) and Levofloxacin + Ceftriaxone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
738 participants
Where
95 sitesin 18 countries
Study dates
Jan 2004to Jul 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

95 sites in 18 countries.

95 sites in 18 countries

France11 sites

  • Study site

    Agen, 47923

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Argenteuil, 95107

  • Study site

    Avignon, 84000

  • Study site

    Belfort, 90016

  • Study site

    Bordeaux, 33000

  • Study site

    Brive-la-Gaillarde, 19100

  • Study site

    Paris, 75014

  • Study site

    Saint-Gaudens, 31806

  • Study site

    Toulon, 83056

  • Study site

    Vesoul, 70014

Other trials in France

Germany8 sites

  • Study site

    Berlin, State of Berlin, 10117

  • Study site

    Berlin, State of Berlin, 13353

  • Study site

    Bochum, North Rhine-Westphalia, 44789

  • Study site

    Bochum, North Rhine-Westphalia, 44791

  • Study site

    Halle, Saxony-Anhalt, 06112

  • Study site

    Lüdenscheid, North Rhine-Westphalia, 58515

  • Study site

    Magdeburg, Saxony-Anhalt, 39112

  • Study site

    Paderborn, North Rhine-Westphalia, 33098

Other trials in Germany

Spain8 sites

  • Study site

    Alcalá de Henares, Madrid, 28805

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Guadalajara, Guadalajara, 19002

  • Study site

    Huesca, Aragon, 22004

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, Madrid, 28008

  • Study site

    Valencia, Valencia, 46014

Other trials in Spain

Mexico7 sites

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    México, D.F., 02290

  • Study site

    México, D.F., 07760

  • Study site

    México, D.F., 14000

  • Study site

    México, D.F., 14080

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Toluca, Edo. de México, 50130

Other trials in Mexico

Poland7 sites

  • Study site

    Bydgoszcz, 85-326

  • Study site

    Gdansk, 80-803

  • Study site

    Krakow, 30-501

  • Study site

    Lodz, 91-425

  • Study site

    Warsaw, 00-909

  • Study site

    Warsaw, 01-138

  • Study site

    Wroclaw, 50-417

Other trials in Poland

South Africa7 sites

  • Study site

    Bloemfontein, Free State

  • Study site

    Bloemfontein, Freestate, 9300

  • Study site

    Brits, Gauteng, 0250

  • Study site

    Cape Town, Western Cape

  • Study site

    Johannesburg, Gauteng, 2132

  • Study site

    Pretoria, Gauteng, 0083

  • Study site

    Somerset West, Western Cape, 7130

Other trials in South Africa

United Kingdom7 sites

  • Study site

    Dumfries, Dumfries and Galloway, DG1 4EP

  • Study site

    Edinburgh, Lothian, EH4 2XU

  • Study site

    Hull, Humberside, HU3 2JZ

  • Study site

    Middlesbrough, Cleveland, TS4 3BW

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Study site

    Rotherham, South Yorkshire, S60 2UD

  • Study site

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Argentina5 sites

  • Study site

    Buenos Aires, Buenos Aires F.D., C1118AAT

  • Study site

    Buenos Aires, Buenos Aires F.D., C1120AAF

  • Study site

    Buenos Aires, Buenos Aires F.D., C1180AAX

  • Study site

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Study site

    Vicente López, Buenos Aires, B1602DOH

Other trials in Argentina

Belgium5 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

  • Study site

    Namur, 5000

Other trials in Belgium

Israel5 sites

  • Study site

    Afula, Israel, 18101

  • Study site

    Ashkelon, Israel, 78306

  • Study site

    Holon, Israel, 58100

  • Study site

    Tel Aviv, Israel, 64239

  • Study site

    Tel HaShomer, 52621

Other trials in Israel

Netherlands5 sites

  • Study site

    's-Hertogenbosch, 5211 RB

  • Study site

    Ede, 6716 RP

  • Study site

    Eindhoven, North Brabant, 5623 EJ

  • Study site

    Harderwijk, 3844 DG

  • Study site

    Heerlen, 6419 PC

Other trials in Netherlands

Lithuania4 sites

  • Study site

    Kaunas, 45130

  • Study site

    Kaunas, 47144

  • Study site

    Vilnius, LT-2001

  • Study site

    Vilnius, LT-2006

Other trials in Lithuania

Sweden4 sites

  • Study site

    Jönköping, 551 85

  • Study site

    Kalmar, 391 85

  • Study site

    Karlstad, 651 85

  • Study site

    Skövde, 541 85

Other trials in Sweden

Chile3 sites

  • Study site

    Santiago

  • Study site

    Temuco, Araucania

  • Study site

    Viña del Mar, Valparaiso

Other trials in Chile

Greece3 sites

  • Study site

    Athens, 11527

  • Study site

    Rio, Patras, 265 04

  • Study site

    Thessaloniki, Thessaloniki, 546 36

Other trials in Greece

Peru3 sites

  • Study site

    Callao, 02

  • Study site

    Lima, 01

  • Study site

    Lima Cercado, LIMA 1

Other trials in Peru

Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Bucaramanga

Other trials in Colombia

Portugal1 site

  • Study site

    Lisbon, 1769-001

Other trials in Portugal

About this study

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

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
Being tested
Avelox (Moxifloxacin, BAY12-8039), Levofloxacin + Ceftriaxone
Keywords
Community-acquired Pneumonia
Medical subject headings
Pneumonia, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avelox (Moxifloxacin, BAY12-8039)Drug

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

  • Levofloxacin + CeftriaxoneDrug

    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 groups in NCT00431678
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2Active comparatorNot described
Receives: Drug: Levofloxacin + Ceftriaxone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response

    Measured: 5 to 7 days after last dose of study medication

Secondary outcomes (8)

  1. Clinical and bacteriological response

    Measured: At the day of switch from intravenous to oral therapy

  2. Clinical and bacteriological response on treatment

    Measured: At day 3 to 5

  3. Clinical and bacteriological response

    Measured: At the end of treatment

  4. Bacteriological response

    Measured: 5-7 days after end of treatment

  5. Mortality attributable to pneumonia

    Measured: 5-7 days after end of treatment

  6. Clinical and bacteriological response

    Measured: At days 21 to 28 after end of treatment

  7. Symptoms course of community-acquired pneumonia

    Measured: at defined visits

  8. Adverse Event Collection

    Measured: all visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2007 (estimated)
  2. Study startJan 2004
  3. Primary completionJul 2005
  4. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
738 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00431678
Sponsor's protocol ID
11215
Status last verified
Dec 2014
First submitted
5 Feb 2007
Last updated
17 Dec 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 18419482

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Levofloxacin + Ceftriaxone in people with Pneumonia, run by Bayer at 95 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in France, Germany, Spain, Mexico, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response (time frame: 5 to 7 days after last dose of study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00431678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.

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