Abstract
Safety and toleration of oral trovafloxacin has been assessed in Phase III trials in patients with acute lower respiratory tract infections. Patients were treated orally with either trovafloxacin 100 or 200 mg (n=881) or a comparator (500 or 1000 mg amoxicillin, or 625 mg amoxicillin/clavulanic acid;n=593). Adverse events were recorded in 112 (12.7%) trovafloxacin- and 74 (12.5%) comparator-treated patients. Frequency of effects on the autonomic nervous, musculoskeletal, respiratory, special senses, urinary and reproductive systems was <1%. Photosensitivity reactions were not reported in trovafloxacin-treated patients. Central or peripheral nervous system adverse effects (headache and dizziness) were slightly more common in trovafloxacin-treated patients (4.4% vs 1.9%). Patients treated with comparators experienced gastrointestinal events more frequently (6.1% vs 8.3%). Comparable incidences of adverse events were reported in patients ≥65-years-old. Most events were mild to moderate in severity. Treatment was discontinued because of an adverse event in 18 (2%) trovafloxacin- and four (0.7%) comparator-treated patients. Despite the high prevalence of risk factors, serious adverse events were rare and the mortality rate over the 35-day study period was low: trovafloxacin 0.8%, comparator agents 1.5%. Laboratory test abnormalities were recorded in less than 1% of patients in either treatment group.
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References
Pechère J-C: Bacteriological activity of trovafloxacin, a new quinolone, against respiratory tract pathogens. European Journal of Clinical Microbiology & Infectious Diseases (1998) 17:405–412
Edelstein PH, Edelstein MAC, Ren J, Polzer R, Gladue RP: Activity of trovafloxacin (CP-99,219) againstLegionella isolates: in vitro activity, intracellular accumulation and killing in macrophages, and pharmacokinetics and treatment of guinea pigs withL. pneumophila pneumonia. Antimicrobial Agents and Chemotherapy (1996) 40:314–319
Vincent J, Teng R, Dogolo L, Baris BA, Willavize SA: Single-and multiple-dose administration, dosing regimens, and pharmacokinetics of trovafloxacin and alatrofloxacin in man. European Journal of Clinical Microbiology & Infectious Diseases (1998) 17:427–430
Vincent J, Venitz J, Teng R, Baris BA, Willavize SA, Polzer SJ, Friedman HL: Pharmacokinetics and safety of trovafloxacin in healthy male volunteers following administration of single intravenous doses of the prodrug, alatrofloxacin. Journal of Antimicrobial Chemotherapy (1997) 39, Supplement B: 75–80
Fischman AJ, Babich JW, Alpert NM, Vincent J, Wilkinson RA, Callaghan RJ, Correia JA, Rubin RH: Pharmacokinetics of 18F-labeled trovafloxacin in normal andEscherichia coli- infected rats and rabbits studied with positron emission tomography. Clinical Microbiology and Infection (1997) 3:63–71
Andrews JM, Honeybourne D, Brenwald NP, Bannerjee D, Iredale M, Cunningham D, Wise R: Concentrations of trovafloxacin in bronchial mucosa, epithelial lining fluid, alveolar macrophages and serum after administration of single or multiple oral doses to patients undergoing fibre-optic bronchoscopy. Journal of Antimicrobial Chemotherapy (1997) 39, Supplement B: 797–802
Hooper DC, Wolfson JS: Adverse effects. In: Hooper DC, Wolfson JS (eds) Quinolone antimicrobial agents. American Society for Microbiology, Washington DC (1993) pp. 489–512
Jüngst G, Mohr R: Overview of postmarketing experience with ofloxacin in Germany. Journal of Antimicrobial Chemotherapy (1988) 22, Supplement C: 167–175
Reiter C, Pfeiffer M, Hullman N: Brief report: safety of ciprofloxacin based on phase IV (“Anwendungsbeobachtung”) in the Federal Republic of Germany. American Journal of Medicine (1989) 87, Supplement A: 103–106
Haria M, Lamb HM: Trovafloxacin. Drags (1997) 54:435–445
O'Doherty B, Daniel R, the Trovafloxacin Bronchitis Study Group: Treatment of acute exacerbations of chronic bronchitis: comparison of trovafloxacin and amoxicillin in a multicentre, double-blind, double-dummy study. European Journal of Clinical Microbiology & Infectious Diseases (1998) 17:441–446
Léophonte P, Baldwin RJT, Pluck N: Trovafloxacin versus amoxicillin/clavulanic acid treatment of acute exacerbations of chronic bronchitis. European Journal of Clinical Microbiology & Infectious Diseases (1998) 17:434–440
Trémolières F, de Kock F, Pluck N: Trovafloxacin versus high-dose amoxicillin (1 g three times daily) in the treatment of community-acquired bacterial pneumonia. European Journal of Clinical Microbiology & Infectious Diseases (1998) 17:447–453
Carbon C, Rubinstein E (eds) Sparfloxacin monograph. Adis International (1994) Chester, p. 45
Rizk E: The US clinical experience with lomefloxacin, a new once-daily fluoroquinolone. American Journal of Medicine (1992) 92, Supplement 4A: 130–135
Gonzalez JP, Henwood JM: Pefloxacin: a review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs (1989) 37:628–668
Norrby SR: Side-effects of quinolones: comparisons between quinolones and other antibiotics. European Journal of Clinical Microbiology & Infectious Diseases (1991) 19:378–383
Iravani A: Multicenter study of single-dose and multiple-dose fleroxacin versus ciprofloxacin in the treatment of uncomplicated urinary tract infections. American Journal of Medicine (1991) 94, Supplement A: 89–96
Stahlmann R: Safety profile of the quinolones. Journal of Antimicrobial Chemotherapy (1990) 26, Supplement D: 31–44
Mayne JT, Johnson NJ, Kluwe WM, Lencoski DL, Polzer RJ: A study of the phototoxic potential of trovafloxacin in BALB/c mice. Journal of Antimicrobial Chemotherapy (1997) 39, Supplement B: 51–55
Maesen FPV, Teengs JP, Baur C, Davies BI: Quinolones and raised plasma concentrations of theophylline. Lancet (1984) ii: 530
Wijnands WJA, VanHerwaarden CLA, Vree T: Enoxacin raises plasma concentrations of theophylline. Lancet (1984) ii: 108–109
Wijnands WJA, Vree T, VanHerwaarden CLA: The influence of quinolone derivatives on theophylline clearance. British Journal of Clinical Pharmacology (1986) 22:677–683
Vincent J, Teng R, Dogolo LC, Willavize SA, Friedman HL: Effect of trovafloxacin, a new fluoroquinolone antibiotic, on the steady-state pharmacokinetics of theophylline in healthy volunteers. Journal of Antimicrobial Chemotherapy (1997) 39, Supplement B: 81–86
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Williams, D., Hopkins, S. Safety of trovafloxacin in treatment of lower respiratory tract infections. Eur. J. Clin. Microbiol. Infect. Dis. 17, 454–458 (1998). https://doi.org/10.1007/BF01691582
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DOI: https://doi.org/10.1007/BF01691582