A 5-day 750mg levofloxacin course is as effective as a 7-14 day regimen in patients with community-acquired pneumonia (CAP) in China
Levofloxacin is widely used for the treatment of community-acquired pneumonia (CAP) and it has been shown in a number of studies that a short-course treatment (750mg IV daily for 5 days) is comparable in efficacy with the conventional levofloxacin regimen (500mg IV daily for 10 days). The present study was carried out to compare the safety and efficacy of levofloxacin 750mg for 5 days with 500mg given intravenously for 7-14 days.
This is the first clinical trial of this nature to be conducted in a Chinese population. It had a multi-center, randomized, open-label, non-inferiority design. Eligible patients were enrolled from 10 clinical centers over the period October 2007 to August 2008 and the study was carried out in accordance with the guidelines of Chinese Good Clinical Practice (GCP). Patients were randomly assigned to levofloxacin 750mg IV daily for 5 days or levofloxacin 500mg IV daily for 7-14 days. Patients of both sexes were recruited and ranged in age from 18-70 years.
Clinical efficacy was assessed at visit 3 and visit 4 and the overall efficacy was determined at visit 4 based on the “Guidelines on Clinical application of antibiotics” issued by the Minister of Health of the People’s Republic of China (MOHC 2004). All patients receiving at least 1 dose of study drug were evaluated with regard to adverse events.
In all, 241 patients were enrolled from 10 study centers with 121 being allocated to the levofloxacin 750mg group and 120 to the levofloxacin 500mg group. The median duration of treatment was 5.0 days for the levofloxacin 750mg group and 7-14 days for the levofloxacin 500mg group.
Evaluation of the clinical efficacy showed that the clinical efficacy in the 750mg group was in no way inferior to that in the 500mg group. Most adverse events were mild and well tolerated.
The mean duration of treatment was significantly shorter in the 750mg group compared with the 500mg group (5.0 days versus 9.5 days) and this reduction offered extra benefits such as reducing the length of hospital stay and cost of treatment. In addition, the safety evaluation showed that the high-dose, short-course treatment had a safety profile that was similar to the conventional treatment.
Overall, this study showed that high-dose, short-course treatment with levofloxacin 750mg IV daily for 5 days has clinical and microbiological efficacy and safety comparable with conventional treatment with 500mg IV daily for 7-14 days.
Diagn Microbiol Infect Dis. 2013 Nov 15. pii: S0732-8893(13)00593-2. doi: 10.1016/j.diagmicrobio.2013.11.008. [Epub ahead of print]
Source : http://www.ncbi.nlm.nih.gov/pubmed/25130297?dopt=Abstract