CHOOSE : Telithromycin, Acute Bacterial Sinusitis

September 24, 2009 updated by: Sanofi

A Prospective, Randomized, Open-label, Active-controlled Study in Adult Subjects With Acute Bacterial Sinusitis Comparing the Clinical Efficacy of Telithromycin (KETEK®) 800 mg Once a Day for 5 Days Versus Amoxicillin-clavulanic Acid (AUGMENTIN®) 875/125 mg Twice a Day for 10 Days

Primary objective:

  • To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS).

Secondary objective(s):

  • To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits,
  • To assess the rate of clinical relapse at the follow-up visit (Day 41-49),
  • To assess health economic outcome until follow-up visit (Day 41-49),
  • To assess quality of life up to the follow-up visit (Day 41-49),
  • To compare the safety of telithromycin and amoxicillin-clavulanic acid,
  • To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non pregnant female
  • Outpatients with a clinical diagnosis of ABS, based on the presence of:

    • Signs and symptoms lasting longer than 7 days and less than 28 days,
    • Purulent anterior or posterior nasal discharge
    • One additional major sign and symptom or 2 minor signs and symptoms. The major and minor signs and symptoms will be defined as the following:

      • Major signs and symptoms: facial pain/pressure/tightness over the maxillary sinuses, nasal congestion/obstruction, change in the perception of smell (hypoanosmia/anosmia), fever (temperature > 38° C [100.4 F] (oral)/ > 38.5° C [101.2 F] (tympanic)/ > 39° C [102.2 F] (rectal)),
      • Minor signs and symptoms: headache, halitosis, dental pain, ear pressure/fullness, cough, fatigue,
  • Subjects with abnormal maxillary sinus x-rays (Waters views and additional views if necessary) or limited sinus CT scans or sinus ultrasound in the previous 48 hours before inclusion defined as the presence of at least 1 of the following homolateral radiological criteria:

    • Presence of air/fluid level,
    • Total opacification,
    • Mucosal thickening > 10 mm, Written informed consent must be obtained before enrollment in the study for all subjects.

Exclusion Criteria:

  • Related to the disease :

    • History of recurrent sinusitis (more than (>) 3 episodes of sinusitis requiring antibiotic therapy within the previous 12 months),
    • Chronic sinusitis (signs and symptoms lasting more than 28 days),
    • Suspicion of sinusitis requiring treatment other than oral antibiotic therapy,
    • Suspicion of concomitant odontologic infection, requiring antibiotic therapy or surgery
    • Nosocomial sinusitis (eg, hospitalization more than 48 hours or non ambulatory institutional confinement including nursing homes within 2 weeks),
    • Known major obstructive anatomic/functional lesions in nasopharynx: anatomical blockage (eg, chronic nasal polyps, severely deviated septum), cystic fibrosis, immotile cilia, sinus polyps,
    • Use of nasal, nasogastric or nasotracheal catheters,
    • Sinus puncture and/or sinus lavage in the previous 7 days,
    • Previous sinus surgery in the last 6 months,
    • Maxillary sinusitis requiring immediate surgery
    • Symptomatic allergic sinusitis and/or allergic rhinitis,
    • Exposition to environmental irritants in the workplace
  • Related to the previous/concomitant medication :

    • Previous treatment with intranasal, oral or parenteral antibiotic (more than 24 hours intake) within 30 days prior enrollment,
    • Intranasal corticosteroid or short term systemic corticosteroid use within the past 10 days prior to enrollment,
    • Maintenance systemic corticosteroid therapy on inclusion (>10 mg/day equivalent prednisone),
    • Subjects who are long-term users (> 4 weeks) of nasal decongestants like oxymetazoline 0.05%,
    • Required on-therapy contra-indicated medications with study treatment (according to the country labeling): ergot alkaloids derivatives (such as ergotamine and dihydroergotamine), cisapride, pimozide, astemizole, terfenadine, simvastatin, atorvastatin and lovastatin, allopurinol, methotrexate, probenecid,
    • Previous treatment within 2 weeks before enrollment or during the study medication with rifampicin, phenytoin, carbamazepine, St-John's-wort, phenobarbital,
    • Treatment with any investigational product in the last 30 days before study entry.
  • Other exclusion criteria

    • Subject with mononucleosis, phenylketonuria,
    • Immunocompromised subjects, such as: subjects with known HIV subjects and those who have either had an AIDS-defining condition (eg, Kaposi's sarcoma, Pneumocystis carinii pneumonia) or have CD4+ T-lymphocyte count < 200/mm3, known neutropenia (< 1500 neutrophils/mm3) not attributable to the acute infectious disease, metastatic or hematological malignancy, splenectomized or known hyposplenia or asplenia,
    • History of congenital or a family history of long QT syndrome (if not excluded by previous ECG),
    • Subjects with known acquired QT interval prolongation,
    • Subjects with myasthenia gravis,
    • Subjects with galactose intolerance,
    • Subjects with a progressively fatal disease, life expectancy £ 3 months,
    • Women who are breast-feeding or are pregnant or childbearing potential (ie, ovulating, premenopausal, not surgically sterile) or who are failing to use adequate contraception for example systemic hormones (birth control pills, implant), intrauterine device or barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom). A urine or serum test will be carry out before enrollment in the study,
    • History or known hypersensitivity and/or adverse reactions to telithromycin or macrolides, amoxycillin-clavulanic acid or betalactams,
    • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult,
    • History of drug or alcohol abuse rendering subjects unable to comply with protocol,
    • Known or history of severe impaired renal function, as shown by a previous laboratory value of creatinine clearance ≤ 30 ml/min either measured or estimated with Cockroft formula or serum creatinine > or =2.0 mg/dL (> or =176 μmol/L),
    • Mental condition rendering the subjects unable to understand the nature, scope, and possible consequences of the study,
    • Subjects unlikely to adhere to the protocol, eg, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study,
    • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the protocol,
    • Subjects having already been included in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical success rate at the TOC visit in the per protocol population.
Time Frame: During all the study conduct
During all the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of regression of signs and symptoms of sinusitis, rate of clinical relapse at follow-up visit.Bacteriological data.Safety data...
Time Frame: During all the study conduct
During all the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Gilles Perdriset, MD, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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