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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00493038
• Other study ID #: 11881
• Secondary ID: 2005-002779-34
• Status: Terminated
• Phase: Phase 4
• First received: June 26, 2007
• Last updated: November 3, 2014
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 293
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Sinusitis

Intervention

Drug:
• Moxifloxacin (Avelox, BAY12-8039)
Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
• Amoxicillin/Clavulanate
Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	At 'Test-of-Cure', Day 1-3 after treatment	No
Secondary	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"	At 'Test-of-Cure', Day 1-3 after treatment	No
Secondary	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"	End of Follow-up, Day 24-30 after treatment	No
Secondary	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.	At 'Test-of-Cure', Day 1-3 after treatment	No
Secondary	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.	End of Follow-up, Day 24-30 after treatment	No

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