Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi
-
J Microbiol Immunol Infect · Oct 2019
Randomized Controlled TrialIntegrated safety summary of phase II and III studies comparing oral nemonoxacin and levofloxacin in community-acquired pneumonia.
Nemonoxacin, a novel nonfluorinated quinolone, has broad-spectrum antibacterial activity, including activity against antibiotic-resistant strains, and was developed for treating community-acquired pneumonia (CAP). This report provides an integrated safety summary of oral nemonoxacin from two phase II and one phase III clinical studies. ⋯ Nemonoxacin was well tolerated and no clinically significant safety concerns were identified, suggesting that it possesses a desirable safety and tolerability profile similar to that of levofloxacin, and may be a suitable alternative to fluoroquinolones for treating patients with CAP.
-
J Microbiol Immunol Infect · Feb 2019
Randomized Controlled Trial Multicenter Study Comparative StudySafety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial.
Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP. ⋯ Nemonoxacin 500 mg once daily for 7-10 days is as effective and safe as levofloxacin for treating adult CAP patients in terms of clinical cure rates, microbiological success rates, and safety profile. ClinicalTrials.gov identifier: NCT01529476.
-
J Microbiol Immunol Infect · Dec 2017
Randomized Controlled Trial Multicenter Study Comparative StudyA randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia.
To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. ⋯ Either 500 mg or 750 mg of oral nemonoxacin taken once daily for 7-10 days demonstrated high clinical and bacteriological success rates in Chinese adult patients with CAP. Nemonoxacin at 500 mg once daily for 7-10 days is recommended for future Phase III clinical trials. ClinicalTrials.gov identifier: NCT01537250.
-
J Microbiol Immunol Infect · Dec 2013
Randomized Controlled TrialThe Madin-Darby canine kidney cell culture derived influenza A/H5N1 vaccine: a phase I trial in Taiwan.
Avian H5N1 influenza has caused human infections globally and has a high mortality rate. Rapid production of effective vaccines is needed. ⋯ MDCK cell line-derived H5N1 vaccine was well tolerated. It is necessary to investigate further the immunogenicity of higher antigen doses and the role of aluminum adjuvant in augmenting the effect of the vaccine.
-
J Microbiol Immunol Infect · Mar 1999
Randomized Controlled Trial Comparative Study Clinical TrialRandomized, double-blind, comparative study of levofloxacin and ofloxacin in the treatment of complicated urinary tract infections.
Levofloxacin, the optical S-(-) isomer of ofloxacin, was compared with ofloxacin in the treatment of complicated urinary tract infections (UTIs). Patients eligible for the trial were randomly assigned to either a daily 300 mg of levofloxacin or 600 mg of ofloxacin for 10 consecutive days. The double blind design was achieved by a double-dummy technique utilizing placebo of both test drugs. ⋯ Four laboratory data abnormalities were observed (defined by 25% as exceeding the normal range), and were considered to not be related to the test medications. Both antibiotics were efficacious in the treatment of complicated UTIs (response rates ranging from 80 to 90%) and were well tolerated. Levofloxacin demonstrated comparable antibacterial effects and safety profiles with double potency dosage, compared to the ofloxacin.