CHOOSE : Telithromycin, Acute Bacterial Sinusitis

NCT00174694 | Completed Phase 4

• 2 other identifiers: HMR3647A_4023EudraCT # : 2004-001460-42
• Study Type: interventional
• Target: 298
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

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

  During all the study conduct

Secondary Outcomes (1)

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

  During all the study conduct

Interventions

Telithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Sanofi: lead

Related Publications (1)

• 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.

  PMID: 18559163 RESULT

MeSH Terms

Conditions

Sinusitis

Interventions

telithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gilles Perdriset, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2005
• Last Updated: September 25, 2009

Record last verified: 2009-09