VON SEGGERN K, RUSSO R, WIKLER MA; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 468.
Bristol-Myers Squibb Company, Plainsboro, NJ
BACKGROUND: A unique phase IV surveillance study, the Tequin Clin. Experience Study (TeqCES) was established to assess the safety and efficacy of gatifloxacin, a recently FDA-approved fluoroquinolone antibiotic in community-based clinical practice.METHODS: TeqCES will enroll 15,000 patients with acute bacterial sinusitis, community-acquired pneumonia (CAP), or acute exacerbation of chronic bronchitis (AECB) at 5,000 community-based practices across the United States. All enrolled patients will be treated with gatifloxacin according to recommended dosing regimens (400 mg orally, once daily; 7-10 days AECB, 10 days acute sinusitis, 7-14 days CAP). In addition to identifying respiratory pathogens, regional pathogen susceptibilities, patient demographics, and clinical outcomes will be recorded for each patient at presentation and during at least one office visit and a follow-up telephone call.RESULTS: Interim safety data have been collected from 4166 patients enrolled in TeqCES (2877 with acute sinusitis; 404 with CAP; 543 with AECB; and unknown for 342). Overall, 764 patients (18.3%) have reported a total of 1,187 adverse events. Only one adverse event (nausea) occurred in >5% of patients [table: see text].CONCLUSIONS: Based on results from TeqCES, gatifloxacin is well tolerated by patients with community-acquired respiratory infections seeking treatment in community-based clinical practices. These results parallel those reported in placebo-controlled clinical trials.KEYWORDS: Gatifloxacin; Respiratory infections; Tolerability
Publication Types:
Keywords:
- Anti-Bacterial Agents
- Bacterial Infections
- Biomedical Research
- Bronchitis, Chronic
- Community-Acquired Infections
- Fluoroquinolones
- Humans
- Pneumonia
- Respiratory Tract Infections
- Sinusitis
- United States
- epidemiology
- gatifloxacin
Other ID:
UI: 102248699
From Meeting Abstracts