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Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis

Primary Purpose

Sinusitis, Bacterial Infections

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Moxifloxacin (Avelox, BAY12-8039)
Amoxicillin/Clavulanate
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring Treatment of acute bacterial rhinosinusitis

Eligibility Criteria

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

Inclusion Criteria:

  • Age >= 18 years
  • Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days
  • Clinical diagnosis will be confirmed by nasal endoscopic examination

Exclusion Criteria:

  • History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
  • Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
  • Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
  • Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required
  • Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
  • Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol
  • Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment
  • Requirement for concomitant therapy with systemic corticosteroids
  • Pregnant or breast feeding
  • Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
  • Received an investigational drug in the past 30 days
  • Previously enrolled in this study
  • Unable to take oral medication
  • History of allergy to quinolone antibiotics or related compounds and beta-lactams
  • History of tendinopathy associated with quinolones
  • Known to have congenital or sporadic syndromes of QT interval corrected for rate (QTc) prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
  • Uncorrected hypokalemia
  • End stage liver cirrhosis (class Child-Pugh C)
  • Severe renal impairment requiring dialysis
  • Diagnosis of rapidly fatal illness with a life expectancy of less than 6 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxifloxacin (Avelox, BAY12-8039)

Amoxicillin/Clavulanate

Arm Description

Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days

Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days

Outcomes

Primary Outcome Measures

Number of Participants With Response (Per-protocol Population)
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"

Secondary Outcome Measures

Number of Participants With Response (Intent-to-treat Population)
Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Number of Participants With Response (Per-protocol Population)
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as "continued clinical cure"
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.

Full Information

First Posted
June 26, 2007
Last Updated
November 3, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00493038
Brief Title
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Official Title
Prospective, Multicenter, Randomized, Double Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg OD for 7 Days Versus a Standard Antibiotic Therapy for 10 Days in the Treatment of Acute Bacterial Rhino Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Bacterial Infections
Keywords
Treatment of acute bacterial rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxifloxacin (Avelox, BAY12-8039)
Arm Type
Experimental
Arm Description
Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days
Arm Title
Amoxicillin/Clavulanate
Arm Type
Active Comparator
Arm Description
Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin (Avelox, BAY12-8039)
Intervention Description
Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin/Clavulanate
Intervention Description
Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
Primary Outcome Measure Information:
Title
Number of Participants With Response (Per-protocol Population)
Description
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Time Frame
At 'Test-of-Cure', Day 1-3 after treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Response (Intent-to-treat Population)
Description
Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Time Frame
At 'Test-of-Cure', Day 1-3 after treatment
Title
Number of Participants With Response (Per-protocol Population)
Description
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as "continued clinical cure"
Time Frame
End of Follow-up, Day 24-30 after treatment
Title
Number of Participants With Response (Microbiologically Valid Patients)
Description
Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Time Frame
At 'Test-of-Cure', Day 1-3 after treatment
Title
Number of Participants With Response (Microbiologically Valid Patients)
Description
Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Time Frame
End of Follow-up, Day 24-30 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days Clinical diagnosis will be confirmed by nasal endoscopic examination Exclusion Criteria: History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included) Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment Requirement for concomitant therapy with systemic corticosteroids Pregnant or breast feeding Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception Received an investigational drug in the past 30 days Previously enrolled in this study Unable to take oral medication History of allergy to quinolone antibiotics or related compounds and beta-lactams History of tendinopathy associated with quinolones Known to have congenital or sporadic syndromes of QT interval corrected for rate (QTc) prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine) Uncorrected hypokalemia End stage liver cirrhosis (class Child-Pugh C) Severe renal impairment requiring dialysis Diagnosis of rapidly fatal illness with a life expectancy of less than 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
San Benedetto del Tronto
State/Province
Ascoli Piceno
ZIP/Postal Code
63039
Country
Italy
City
Esine
State/Province
Brescia
ZIP/Postal Code
25040
Country
Italy
City
Lamezia Terme
State/Province
Catanzaro
ZIP/Postal Code
88046
Country
Italy
City
Cesena
State/Province
Forlì
ZIP/Postal Code
47023
Country
Italy
City
Sestri Ponente
State/Province
Genova
ZIP/Postal Code
16154
Country
Italy
City
Monza
State/Province
Monza-Brianza
ZIP/Postal Code
20052
Country
Italy
City
Comiso
State/Province
Ragusa
ZIP/Postal Code
97013
Country
Italy
City
Bari
ZIP/Postal Code
70123
Country
Italy
City
Benevento
ZIP/Postal Code
82100
Country
Italy
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
City
Caserta
ZIP/Postal Code
81100
Country
Italy
City
Catania
ZIP/Postal Code
95123
Country
Italy
City
Catania
ZIP/Postal Code
95126
Country
Italy
City
Firenze
ZIP/Postal Code
50126
Country
Italy
City
Foggia
ZIP/Postal Code
71100
Country
Italy
City
Lecce
ZIP/Postal Code
73100
Country
Italy
City
Lecco
ZIP/Postal Code
23900
Country
Italy
City
Matera
ZIP/Postal Code
75100
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20142
Country
Italy
City
Novara
ZIP/Postal Code
28100
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Perugia
ZIP/Postal Code
06122
Country
Italy
City
Pisa
ZIP/Postal Code
56126
Country
Italy
City
Roma
ZIP/Postal Code
00135
Country
Italy
City
Roma
ZIP/Postal Code
00151
Country
Italy
City
Roma
ZIP/Postal Code
00184
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Torino
ZIP/Postal Code
10126
Country
Italy
City
Torino
ZIP/Postal Code
10141
Country
Italy
City
Treviso
ZIP/Postal Code
31100
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 of Bayer products for Europe

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis

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