| Title | Clinical evaluation of oral levofloxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China |
| Authors | Zhang, Ying-yuan Huang, Hai-hui Ren, Zhen-yi Zheng, Hong-guang Yu, Yun-song Lue, Xiao-ju Xiao, Zu-ke Yang, Hui-fen Xiu, Qing-yu Chen, Bao-yuan Yue, Hong-mei Hao, Qing-lin Huang, Jian-an Ma, Hui Xiao, Wei Guo, Dong-yang Si, Bin Sun, Sheng-hua Zhang, Wei Li, Qi-hao Shen, Hua-hao Duan, Jian Li, Hua-yin Yao, Wan-zhen Gu, Jun-ming Xia, Qian-ming Ying, Ke-jing Liu, Ao Yang, He-ping Shi, Min-hua Sun, Tie-ying Ding, Guo-hua Wu, Guo-ming |
| Affiliation | Fudan Univ, Inst Antibiot, Huashan Hosp, Shanghai 200040, Peoples R China. First Peoples Hosp Hangzhou, Dept Resp Med, Hangzhou, Zhejiang, Peoples R China. Mil Gen Hosp Shenyang, Dept Nephrol, Shenyang, Peoples R China. Zhejiang Univ, Dept Infect Dis, Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China. Sichuan Univ, Dept Infect Dis, Huaxi Hosp, Chengdu 610064, Peoples R China. Peoples Hosp Jiangxi Prov, Dept Resp Med, Nanchang, Peoples R China. Tianjin Med Univ, Hosp 2, Dept Infect Dis, Tianjin, Peoples R China. Shanghai Changzheng Hosp, Dept Resp Med, Shanghai, Peoples R China. Tianjin Med Univ, Dept Resp Med, Gen Hosp, Tianjin, Peoples R China. Lanzhou Univ, Hosp 1, Dept Resp Med, Lanzhou 730000, Peoples R China. Kunming Med Univ, Dept Resp Med, Hosp 1, Kunming, Peoples R China. Suzhou Univ, Hosp 1, Dept Resp Med, Suzhou 215006, Peoples R China. Peoples Hosp Gansu Prov, Dept Resp Med, Lanzhou, Peoples R China. Shangdong Univ, Dept Resp Med, Qilu Hosp, Jinan, Peoples R China. Mil Gen Hosp Chengdu, Dept Nephrol, Chengdu, Peoples R China. Mil Gen Hosp Wuhan, Dept Resp Med, Wuhan, Peoples R China. Zhongnan Univ, Xiangya Hosp 3, Dept Resp Med, Changsha, Hunan, Peoples R China. Nanchang Univ, Hosp 1, Dept Resp Med, Nanchang, Peoples R China. Kunming Med Univ, Hosp 2, Dept Resp Med, Kunming, Peoples R China. Zhejiang Univ, Dept Resp Med, Hosp 2, Hangzhou 310003, Zhejiang, Peoples R China. Mil Gen Hosp Kunming, Dept Nephrol, Kunming, Peoples R China. Fudan Univ, Zhongshan Hosp, Dept Resp Med, Shanghai 200040, Peoples R China. Peking Univ, Dept Resp Med, Hosp 3, Beijing 100871, Peoples R China. Dalian Med Univ, Hosp 2, Dept Resp Med, Dalian, Peoples R China. Mil Gen Hosp Chengdu, Dept Resp Med, Chengdu, Peoples R China. Zhejiang Univ, Dept Resp Med, Sir Run Run Shaw Hosp, Hangzhou 310003, Zhejiang, Peoples R China. Mil Gen Hosp Kunming, Dept Resp Med, Kunming, Peoples R China. Third Mil Med Univ, Hosp 1, Dept Resp Med, Chongqing, Peoples R China. Suzhou Univ, Hosp 2, Dept Resp Med, Suzhou 215006, Peoples R China. Beijing Hosp, Dept Resp Med, Beijing, Peoples R China. Wuhan Univ, Dept Nephrol, Peoples Hosp, Wuhan 430072, Peoples R China. Third Mil Med Univ, Hosp 2, Dept Resp Med, Chongqing, Peoples R China. Fudan Univ, Inst Antibiot, Huashan Hosp, 12 Wulumuqi Zhong Lu, Shanghai 200040, Peoples R China. |
| Keywords | Lower respiratory tract infection Urinary tract infection Levofloxacin Clinical study STREPTOCOCCUS-PNEUMONIAE ANTIMICROBIAL RESISTANCE PHARMACODYNAMICS PHARMACOKINETICS FLUOROQUINOLONES CIPROFLOXACIN SURVEILLANCE AGENTS MODEL |
| Issue Date | 2009 |
| Publisher | journal of infection and chemotherapy |
| Citation | JOURNAL OF INFECTION AND CHEMOTHERAPY.2009,15,(5),301-311. |
| Abstract | Levofloxacin (LVFX), a fluoroquinolone agent, has a broad spectrum that covers Gram-positive and -negative bacteria and atypical pathogens. It demonstrates good clinical efficacy in the treatment of various infections, including lower respiratory tract infections (LRTIs) and urinary tract infections (UTIs). To evaluate the efficacy and safety of oral LVFX 500 mg once daily, a large open-label clinical trial was conducted in 1266 patients (899 with LRTIs and 367 with UTIs) at 32 centers in China. In the per-protocol population, the clinical efficacy rate (cure or improvement) at 7 to 14 days after the end of treatment was 96.4% (666/691) for LRTIs and 95.7% (267/279) for UTIs. In 53 patients diagnosed with atypical pneumonia the treatment was effective. The bacteriological efficacy rate was 96.6% (256/265) for LRTIs and 93.3% (126/135) for UTIs. The eradication rate of the causative pathogens was 100% (33/33) for Haemophilus influenzae and 96.0% (24/25) for Streptococcus pneumoniae in LRTIs, and 94.1% (80/85) for Escherichia coli in UTIs. The overall efficacy rates were 89.3% (617/691) for LRTIs and 87.8% (245/279) for UTIs. The incidence of drug-related adverse events (ADRs) was 17.3% (215/1245), and the incidence of drug-related laboratory abnormalities was 15.7% (191/1213). Common ADRs were dizziness, nausea, and insomnia. Common laboratory abnormalities included "WBC decreased", "alanine aminotransferase (ALT) increased", "aspartate aminotransferase (AST) increased", and "lactate dehydrogenase (LDH) increased". All of these events were mentioned in the package inserts of fluoroquinolones including LVFX, and most events were mild and transient. Thirty-four patients (2.7%) were withdrawn from the study because of the ADRs. No new ADRs were found. This study concluded that the dosage regimen of LVFX 500 mg once daily was effective and tolerable for the treatment of LRTIs and UTIs. |
| URI | http://hdl.handle.net/20.500.11897/246213 |
| ISSN | 1341-321X |
| DOI | 10.1007/s10156-009-0713-9 |
| Indexed | SCI(E) |
| Appears in Collections: | 第三医院 |
