A phase II study of antofloxacin hydrochloride, a novel fluoroquinolone, for the treatment of acute bacterial infections.

Abstract

AIMS:

To evaluate the clinical and bacterial efficacies and the safety of antofloxacin hydrochloride tablets in the treatment of acute exacerbations of chronic bronchitis (AECB) and acute pyelonephritis (AP).

PATIENTS AND METHODS:

A randomized, controlled, multicenter, double-blind, double-dummy clinical trial was conducted at 6 hospitals in China. The patients in the investigational group took an oral 400-mg loading dose of antofloxacin on the first day followed by 200 mg daily. Control group patients took 200 mg of levofloxacin orally twice daily for 7-14 days.

RESULTS:

A total of 284 patients were enrolled into the study, including 140 cases of AECB and 144 cases of AP; 141 patients were in the antofloxacin group and 143 patients were in the levofloxacin group. Two hundred fifty-four patients completed the entire treatment and follow-up and comprised the per-protocol analysis data set; 30 patients were excluded because of informed consent withdrawal, loss to follow-up, protocol violations, or adverse drug events. Treatment was ceased in 3 patients in the antofloxacin group and in 1 patient in the levofloxacin group because of skin rashes, dizziness, or adverse gastrointestinal effects. At the end of the 2-regimen treatment, the observed effectiveness rates for AECB were 90.3 and 87.7% for the treatment and control groups, respectively, and 96.9 and 92.1% for AP. The overall bacterial eradication rates were 95.9 and 92.4%, and drug-related adverse events were observed in 13.1 and 10.1% of patients, respectively. There were no severe adverse effects. No statistical differences in drug efficacy and safety were detected between the 2 treatment groups (p > 0.05).

CONCLUSIONS:

Antofloxacin hydrochloride is an effective and well-tolerated new fluoroquinolone that demonstrates clinical and bacteriological efficacies similar to levofloxacin for the treatment of AECB and AP.

• Authors: Jin Wang, Yonghong Xiao, Wenxiang Huang, Nan Xu, Chunxue Bai, Qingyu Xiu, Changlin Mei, Qingshan Zheng
• Journal: Chemotherapy (Chemotherapy) Vol. 56 Issue 5 Pg. 378-85 ( 2010) ISSN: 1421-9794 [Electronic] Switzerland
• PMID: 20938175 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 S. Karger AG, Basel.

Chemical References

• Anti-Bacterial Agents
• antofloxacin
• Levofloxacin
• Ofloxacin

Topics

• Acute Disease
• Adult
• Aged
• Anti-Bacterial Agents (pharmacokinetics, therapeutic use)
• Bronchitis, Chronic (drug therapy)
• Demography
• Double-Blind Method
• Female
• Humans
• Levofloxacin
• Male
• Middle Aged
• Ofloxacin (analogs & derivatives, pharmacokinetics, therapeutic use)
• Pyelonephritis (drug therapy)