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.
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 Thirty-four patients (2.7%) were withdrawn from the study because of the ADRs.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.
Zhang
Ying-Yuan
YY
Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Wulumuqi Zhong Lu, Shanghai 200040, China. yyzhang@hsh.stn.sh.cn
Huang
Hai-Hui
HH
Ren
Zhen-Yi
ZY
Zheng
Hong-Guang
HG
Yu
Yun-Song
YS
Lü
Xiao-Ju
XJ
Xiao
Zu-Ke
ZK
Yang
Hui-Fen
HF
Xiu
Qing-Yu
QY
Chen
Bao-Yuan
BY
Yue
Hong-Mei
HM
Hao
Qing-Lin
QL
Huang
Jian-An
JA
Ma
Hui
H
Xiao
Wei
W
Guo
Dong-Yang
DY
Si
Bin
B
Sun
Sheng-Hua
SH
Zhang
Wei
W
Li
Qi-Hao
QH
Shen
Hua-Hao
HH
Duan
Jian
J
Li
Hua-Yin
HY
Yao
Wan-Zhen
WZ
Gu
Jun-Ming
JM
Xia
Qian-Ming
QM
Ying
Ke-Jing
KJ
Liu
Ao
A
Yang
He-Ping
HP
Shi
Min-Hua
MH
Sun
Tie-Ying
TY
Ding
Guo-Hua
GH
Wu
Guo-Ming
GM
D000284:Administration, Oral; D000293:Adolescent; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D004244:Dizziness / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D028761:Withholding Treatment / Q000706:statistics & numerical data
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D015242:Ofloxacin