MONTREAL — Short-course therapy with oral gemifloxacin is effective for the treatment of mild to moderate community-acquired pneumonia, including that caused by multidrug resistant Streptococcus pneumoniae, a study has shown.
The findings add to a growing body of evidence suggesting that the optimal duration of antimicrobial therapy may be shorter than current practice prescribes, Thomas M. File Jr., M.D., reported in a poster presentation at an international conference on community-acquired pneumonia (CAP).
Proponents of short-course antimicrobial therapy for community-acquired pneumonia believe that shorter duration therapy might enhance compliance, reduce development of antimicrobial resistance, decrease the incidence and shorten the duration of adverse drug effects, cut treatment costs, and improve patient satisfaction with therapy, he said.
To compare the efficacy of 5-day gemifloxacin treatment with the standard 7-day course, Dr. File, professor of internal medicine at Northeastern Ohio Universities, Rootstown, and his colleagues enrolled 510 patients with mild to moderate CAP in a multicenter, double-blind study. Of the 468 patients who completed the entire treatment protocol, 242 were randomized to receive 320 mg of oral gemifloxacin (Factive) for 5 days, while 226 were given the same dose of the drug for the standard 7 days.
Measures of clinical response at the end of treatment showed a 96% response rate for both the 5-day and 7-day groups. At follow-up (2–3 weeks after treatment), the clinical response rate was 95% for the 5-day group and 92% for the 7-day group, Dr. File reported.
The bacteriological response rates were 94% and 96% for the 5-day and 7-day groups, respectively, at the end of treatment, and were 91% for both groups at follow-up. The radiological response rates, measured only at follow-up, were 98% for the 5-day patients and 95% for those taking the drug for 7 days. None of the differences was statistically significant, he said.
The 5-day dose of gemifloxacin eradicated S. pneumoniae—including five multidrug-resistant strains—in all 26 individuals in which the pathogen was identified. In the 7-day patients, the drug eradicated 87% of the S. pneumoniae, including four of six multidrug-resistant strains.
In terms of safety, the drug was well tolerated in both groups. “Withdrawal due to adverse events was only 1.2% for the 5-day group and 2.0% for the 7-day group,” Dr. File noted. The most common adverse event reported was a laboratory finding of elevated liver enzymes, but a subsequent analysis showed no association between the increase in these laboratory findings and treatment with gemifloxacin, nor did patients display hepatotoxic effects. The rates of drug-related rash were also low in both treatment groups.
Gemifloxacin is the most potent agent among the fluoroquinolones for the treatment of respiratory tract infections, “and more and more we are seeing the benefits of using a short course of the most potent antimicrobial drug in a class for treating infections such as community-acquired pneumonia,” he said.