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SinusitisPhase 4NCT00174694

CHOOSE : Telithromycin, Acute Bacterial Sinusitis

A Phase 4 study testing Telithromycin in people with Sinusitis, run by Sanofi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sinusitis
What is being tested?
Telithromycin
How many people
298 participants
Where
No sites listed yet
Study dates
Nov 2004to Dec 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)),
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  • 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.

Who cannot join

  • 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),
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  • 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.

About this study

Official title: 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).
Read more

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.
Conditions
Sinusitis
Being tested
Telithromycin
Medical subject headings
Sinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelithromycinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical success rate at the TOC visit in the per protocol population.

    Measured: During all the study conduct

Secondary outcomes (1)

  1. Time of regression of signs and symptoms of sinusitis, rate of clinical relapse at follow-up visit.Bacteriological data.Safety data...

    Measured: During all the study conduct

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00174694
Sponsor's protocol ID
HMR3647A_4023
Other IDs
EudraCT # : 2004-001460-42
Status last verified
Sep 2009
First submitted
9 Sep 2005
Last updated
25 Sep 2009
Results posted
No

Publications

  • Desrosiers M, Ferguson B, Klossek JM, Drugeon H, Mosges R. Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin-clavulanate in the treatment of acute bacterial sinusitis. Curr Med Res Opin. 2008 Jun;24(6):1691-702. doi: 10.1185/03007990802133914.

    PubMed 18559163

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telithromycin in people with Sinusitis, run by Sanofi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical success rate at the TOC visit in the per protocol population. (time frame: During all the study conduct). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00174694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.

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