Clinical phase II study of garenoxacin in patients with respiratory tract infections: Open-label, multi-center, non-comparative

Japanese Journal of Chemotherapy

Volumn 55, Issue SUPPL. 1, 2007, Pages 116-126

  Kobayashi, Hiroyuki ^a   Watanabe, Akira ^b   Aoki, Nobuki ^c   Odagiri, Shigeki ^d,g   Sano, Yasuyuki ^e,h   Saito, Atsushi ^f,i  

^a KYORIN UNIVERSITY   (Japan)

^b TOHOKU UNIVERSITY   (Japan)

^c Shinrakuen Hospital   (Japan)

^d Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center Hospital   (Japan)

^e Department of Allergy and Respiratory Diseases   (Japan)

^f UNIVERSITY OF THE RYUKYUS   (Japan)

^g Odagiri Respiratory Disease Clinic   (Japan)

^h Sano Toranomon Clinic   (Japan)

ⁱ JAPANESE RED CROSS SOCIETY   (Japan)

Author keywords

Clinical study; Des fluoro(6) quinolone; Garenoxacin; Respiratory infection

Indexed keywords

GARENOXACIN;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ARTICLE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG STRUCTURE; FEMALE; HUMAN; INFECTION CONTROL; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PROGNOSIS; RESPIRATORY TRACT INFECTION; SIDE EFFECT; STRUCTURE ANALYSIS; UNSPECIFIED SIDE EFFECT;

EID: 35348963137     PISSN: 13407007     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. Hayashi K, Takahata M, Kawamura Y, Todo Y: Synthesis, antibacterial activity, and toxicity of 7-(isoindolin-5-yl)-4-oxoquinoline-3-carboxylic acids. Discovery of the novel des-F(6)-quinolone antibacterial agent garenoxacin (T-3811 or BMS-284756). Arzneimittelforschung 2002; 52: 903-13
2. Takahata M, Mitsuyama J, Yamashiro Y, Yonezawa M, Araki H, Todo Y, et al: In vitro and in vivo antimicrobial activities of T-3811 ME, a novel des-F(6)-quinolone. Antimicrob Agnets Chemother 1999; 43: 1077-84
3. Van Wart S, Phillips L, Ludwing E A, Russo R, Gajjar D A, Bello A, et al: Population pharmacokinetics and pharmacodynamics of garenoxacin in patients with community-acquired respiratory tract infections. Antimicrob Agents Chemother 2004; 48: 4766-77
4. Japanese source.
5. Japanese source.
6. Andes D, Craig W A: Pharmacodynamics of the new des-F(6)-quinolone garenoxacin in a murine thigh infection model. Antimicrob Agents Chemother 2003; 47: 3935-41
7. Points to consider: The assesment of the potential for QT interval prolongation by non-cardiovascular medicinal products. EMEA/CPMP 986/96, 1997
8. ICH harmonized tripartite guideline: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs E14, recommended for adoption at step 4 of the ICH process. May 12, 2005
9. Chen H J, Bloch K J, Maclean J A: Acute eosinophilic hepatitis from trovafloxacin. N Engl J Med 2000; 342: 359-60