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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sinusitis; Bacterial Infections

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Amoxicillin/Clavulanate (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

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

Primary outcome: Number of Participants With Response (Per-protocol Population)

Secondary outcome:

Number of Participants With Response (Intent-to-treat Population)

Number of Participants With Response (Per-protocol Population)

Number of Participants With Response (Microbiologically Valid Patients)

Number of Participants With Response (Microbiologically Valid Patients)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bari 70123, Italy

Benevento 82100, Italy

Bergamo 24128, Italy

Bologna 40138, Italy

Bolzano 39100, Italy

Caserta 81100, Italy

Catania 95126, Italy

Catania 95123, Italy

Firenze 50126, Italy

Foggia 71100, Italy

Lecce 73100, Italy

Lecco 23900, Italy

Matera 75100, Italy

Milano 20142, Italy

Milano 20122, Italy

Novara 28100, Italy

Pavia 27100, Italy

Perugia 06122, Italy

Pisa 56126, Italy

Roma 00135, Italy

Roma 00151, Italy

Roma 00184, Italy

Siena 53100, Italy

Torino 10126, Italy

Torino 10141, Italy

Treviso 31100, Italy

Udine 33100, Italy

San Benedetto del Tronto, Ascoli Piceno 63039, Italy

Esine, Brescia 25040, Italy

Lamezia Terme, Catanzaro 88046, Italy

Cesena, Forlì 47023, Italy

Sestri Ponente, Genova 16154, Italy

Monza, Monza-Brianza 20052, Italy

Comiso, Ragusa 97013, Italy

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Click here and search for information of Bayer products for Europe

Starting date: February 2006
Last updated: November 3, 2014

Page last updated: August 23, 2015

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