AMS VS MOXI Ketek vs Avelox in AMS

NCT00537563 | Completed Phase 3

• 1 other identifier: HMR3647A_4017
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure visit, and to assess the safety of telithromycin given once daily for 5 days vs moxifloxacin given once daily for 10 days in the treatment of subjects with AMS.

Conditions

Maxillary Sinusitis

Outcome Measures

Primary Outcomes (1)

• To demonstrate equivalence in clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure (TOC) visit.

  Days 17 to 24

Secondary Outcomes (1)

• Assess the safety of telithromycin given once daily for 5 days vs moxifloxacin given once daily for 10 days in the treatment of subjects with AMS.

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:

• Adult subjects, aged 18 years or older, AMS diagnosed (clinically and radiologically) who were willing to undergo rhinoscopic aspiration or deep nasal swab at the baseline/pre-therapy visit. Female subjects of childbearing potential were required to have a negative pregnancy test before undergoing any study procedure and to use an accepted contraceptive method during the study.

You may not qualify if:

• Women who were breast-feeding or pregnant, as demonstrated by serum or urine pregnancy tests carried out before exposure to study medication or the start of any study procedure that could pose a risk to the fetus;
• Subjects with a history of recurrent sinusitis (defined as more than 3 episodes of sinusitis that required antibiotic therapy in the preceding 12 months);
• Subjects with a history of chronic sinusitis (defined as symptoms lasting greater than 28 days);
• Subjects with sphenoidal sinusitis involvement that required treatment other than oral antibiotics;
• Subjects with nosocomial-acquired sinusitis within 2 weeks (eg, hospitalization or nonambulatory, institutional confinement, including nursing homes);
• Subjects with any concomitant medication \[including functionally significant, major obstructive anatomical lesions likely to impair resolution of infection (eg, nasal polyps extending past the middle turbinate, tumor, or severe septal deviation)\], such as: asthma, cystic fibrosis, immotile cilia syndrome, prior nasopharyngeal or sinus surgery, sinus polyps, clinically relevant cardiovascular (eg, congestive heart failure), neurologic, endocrine, or other major systemic disease that could have made implementation of the protocol or interpretation of the study results difficult;
• Subjects with a need for immediate surgery for maxillary sinusitis;
• Subjects who used nasal, nasogastric, or nasotracheal catheters;
• Subjects with previous sinus surgery within the past 6 months or sinus lavage within the past 7 days;
• Subject who were long-term (\> than or = to 4 weeks) users of nasal decongestants like oxymetazoline 0.05%;
• Subjects with suspected nonbacterial infections;
• Subjects with a concomitant odontological infection that would require antibiotic therapy or surgery;
• Subjects with unknown or suspected hypersensitivity to, or a known or suspected serious adverse reaction to either study medication, any fluoroquinolone, or any macrolide antibiotic;
• Subjects who would likely have required on-study treatment with drugs known to have contraindicated drug interactions with either study medication and/or macrolides or fluoroquinolones in general, including, but not limited to: ergot alkaloid derivatives, cholinesterase inhibitors (eg, tacrine, donepezil, physostigmine) ketamine, carbamazepine, St John's Wort, Class IA (eg, quinidine, procainamide), or Class III antiarrhythmic agents (eg, amiodarone, sotalol);
• Subjects who required anticoagulant therapy (eg, warfarin);

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Maxillary Sinusitis

Interventions

telithromycin

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: December 1, 2002
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)