The efficacy of
telithromycin has been assessed in six Phase III studies involving adults with mild to moderate community-acquired
pneumonia (CAP) with a degree of severity compatible with oral
therapy. Patients received
telithromycin 800 mg once daily for 7-10 days in three open-label studies (n=870) and three randomized, double-blind, comparator-controlled studies (n=503). Comparator antibacterials were
amoxicillin 1000 mg three-times daily,
clarithromycin 500 mg twice daily and
trovafloxacin 200 mg once daily. Clinical and bacteriological outcomes were assessed 7-14 days post-
therapy. Among
telithromycin-treated patients, per-protocol clinical cure rates were 93.1 and 91.0% for the open-label and comparative studies, respectively.
Telithromycin treatment was as effective as the comparator agents. High eradication and clinical cure rates were observed for
infections caused by key pathogens: Streptococcus pneumoniae including isolates resistant to
penicillin G and/or
erythromycin A (95.4%), Haemophilus influenzae (89.5%) and Moraxella catarrhalis (90%).
Telithromycin was also highly effective in patients with
infections caused by atypical and/or intracellular pathogens and those at increased risk of morbidity.
Telithromycin was generally well tolerated.
Telithromycin 800 mg once daily for 7-10 days offers a convenient and well-tolerated first-line oral
therapy for the empirical treatment of mild to moderate CAP.