Back to results

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

Primary Purpose

Pneumonia

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Avelox (Moxifloxacin, BAY12-8039)

Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring CAP, Community-acquired pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
- 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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Bacteriological response at TOC

Clinical and bacteriological response at the end of treatment

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

Full Information

NCT ID

NCT00717561

First Posted

July 16, 2008

Last Updated

November 2, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00717561

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

CAP, Community-acquired pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Avelox (Moxifloxacin, BAY12-8039)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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

Time Frame

Day of switch from IV to oral therapy

Title

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

Time Frame

Day 3-5

Title

Bacteriological response at TOC

Time Frame

20 days after last dose of study drug

Title

Clinical and bacteriological response at the end of treatment

Time Frame

Day 7-14 after first dose of study drug

Title

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

Time Frame

20 days after last dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Lungro

State/Province

Cosenza

ZIP/Postal Code

87010

Country

Italy

City

San Cesario

State/Province

Lecce

ZIP/Postal Code

73016

Country

Italy

City

Fossombrone

State/Province

Pesaro e Urbino

ZIP/Postal Code

61034

Country

Italy

City

Pregiato di Cava dei Tirreni

State/Province

Salerno

ZIP/Postal Code

84013

Country

Italy

City

Vittorio Veneto

State/Province

Treviso

ZIP/Postal Code

31029

Country

Italy

City

Ascoli Piceno

ZIP/Postal Code

63100

Country

Italy

City

Benevento

ZIP/Postal Code

82100

Country

Italy

City

Brescia

ZIP/Postal Code

25123

Country

Italy

City

Catania

ZIP/Postal Code

95122

Country

Italy

City

Chieti

ZIP/Postal Code

66100

Country

Italy

City

Foggia

ZIP/Postal Code

71100

Country

Italy

City

Lucca

ZIP/Postal Code

55100

Country

Italy

City

Macerata

ZIP/Postal Code

62100

Country

Italy

City

Messina

ZIP/Postal Code

98125

Country

Italy

City

Milano

ZIP/Postal Code

20142

Country

Italy

City

Milano

ZIP/Postal Code

20157

Country

Italy

City

Palermo

ZIP/Postal Code

90146

Country

Italy

City

Roma

ZIP/Postal Code

00135

Country

Italy

City

Roma

ZIP/Postal Code

00168

Country

Italy

City

Roma

ZIP/Postal Code

00184

Country

Italy

City

Sassari

ZIP/Postal Code

07100

Country

Italy

City

Torino

ZIP/Postal Code

10154

Country

Italy

City

Udine

ZIP/Postal Code

33100

Country

Italy

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu

Description

Click here and search for information provided by EMA

Learn more about this trial

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

We'll reach out to this number within 24 hrs