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PneumoniaPhase 3NCT00717561

A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin in people with Pneumonia, run by Bayer at 23 sites in Italy.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia. 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 Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
23 sitesItaly
Study dates
Feb 2008to Jun 2009
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

  • Hospitalized non-ICU patients (age, >= 18 years)
  • Clinical signs and symptoms of CAP, with PSI score IV or V
  • Radiologically confirmed evidence of a new and/or progressive infiltrate(s)
  • Requirement for initial parenteral therapy
  • At least 2 of the following conditions:
  • Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum
Show all 12Show fewer
  • Dyspnea and/or tachypnea (respiratory rate of > 20 breaths/min)
  • Rigors and/or chills
  • Pleuritic chest pain
  • Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation
  • Fever (an oral temperature of >= 38 °C, a rectal temperature of >= 39 °C, or a tympanic temperature of >= 38.5 °C) or hypothermia (rectal or core temperature of < 35 °C), and a WBC count of >= 10,000 cells/mm3 or >= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of < 4500 cells/mm3)
  • Written informed consent

Who cannot join

  • PSI Class I-III and V with need for ICU admission
  • Hospitalization for > 48 hours before developing pneumonia, or discharge from hospital < 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Italy23 sites

  • Study site

    Ascoli Piceno, 63100

  • Study site

    Benevento, 82100

  • Study site

    Brescia, 25123

  • Study site

    Catania, 95122

  • Study site

    Chieti, 66100

  • Study site

    Foggia, 71100

  • Study site

    Fossombrone, Pesaro e Urbino, 61034

  • Study site

    Lucca, 55100

  • Study site

    Lungro, Cosenza, 87010

  • Study site

    Messina, 98125

  • Study site

    Milan, 20142

  • Study site

    Milan, 20157

  • Study site

    Palermo, 90146

  • Study site

    Pregiato Di Cava Dei Tirreni, Salerno, 84013

  • Study site

    Province of Macerata, 62100

  • Study site

    Roma, 00135

  • Study site

    Roma, 00168

  • Study site

    Roma, 00184

  • Study site

    San Cesario di Lecce, Lecce, 73016

  • Study site

    Sassari, 07100

  • Study site

    Torino, 10154

  • Study site

    Udine, 33100

  • Study site

    Vittorio Veneto, Treviso, 31029

Other trials in Italy

About this study

Official title: A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia

The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.

Conditions
Pneumonia
Being tested
Avelox (Moxifloxacin, BAY12-8039), Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin
Keywords
CAP, 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

    IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours

  • Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; ClarithromycinDrug

    IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.

Study groups in NCT00717561
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2Active comparatorNot described
Receives: Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

What is being measured

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

  1. Clinical response 20 days after completion of study treatment (Test-of-Cure visit)

    Measured: 20 days after last dose of study drug (TOC Visit)

Secondary outcomes (5)

  1. Clinical and bacteriological response on the day of switch from IV to oral therapy

    Measured: Day of switch from IV to oral therapy

  2. Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)

    Measured: Day 3-5

  3. Bacteriological response at TOC

    Measured: 20 days after last dose of study drug

  4. Clinical and bacteriological response at the end of treatment

    Measured: Day 7-14 after first dose of study drug

  5. Mortality attributable to pneumonia at the Test-of-Cure visit

    Measured: 20 days after last dose of study drug

Timeline

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

  1. First posted17 Jul 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionMay 2009
  4. Study completionJun 2009

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
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00717561
Sponsor's protocol ID
12669
Other IDs
2007-001320-12
Status last verified
Oct 2014
First submitted
16 Jul 2008
Last updated
4 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin in people with Pneumonia, run by Bayer at 23 sites in Italy.

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 12 inclusion and 2 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy. 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 20 days after completion of study treatment (Test-of-Cure visit) (time frame: 20 days after last dose of study drug (TOC Visit)). 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 NCT00717561.

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 4 Nov 2014.

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