AMS VS MOXI Ketek vs Avelox in AMS

Completed · Phase 3

Conditions studied: Maxillary Sinusitis

In brief

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.

Key facts

Study ID

NCT00537563

Run by

Sanofi

People needed

351

Starts

2002-12-01

Expected to finish

2003-09-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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);
• Subjects who received treatment with other systemic antibiotics (oral or parenteral) within 14 days prior to study enrollment;
• Subject who received moxifloxacin or another fluoroquinolone antibiotic for this infectious episode;
• Likelihood of required treatment during the study period with drugs not permitted by the protocol;
• Treatment with any investigational product in the last 1 month prior to study entry;
• Subjects with a progressively fatal disease; life expectancy <less than or = to 3 months;
• 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;
• Impaired hepatic function [as shown by previous clinical laboratory values of AST (SGOT) and/or ALT (SGPT) > than or = to 3 times the upper limit of reference range, total bilirubin > than 2 times the upper limit of reference range (except for Gilbert's disease), encephalopathy, etc];
• Impaired renal function [as shown by previous clinical laboratory values of creatinine clearance < than or = to 30 mL/min (< than or = to 0.50 mL/sec), serum creatinine > than or = to 2.0 mg/dl (> than or = to 176 micromol/L), etc]. Creatinine clearance may have been estimated by formula or by nomogram;
• Immunocompromised subjects, such as subjects with HIV infection and who had either an AIDS-defining condition (eg, Kaposi's sarcoma and Pneumocystis carinii pneumonia), or a CD4 + T-lymphocyte count of < 200/mm3). A complete list is provided in Appendix 3 of the clinical study protocol (see @@Appendix A.1.1).

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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