Back

Telithromycin versus other first-line single-agent antibiotics in the treatment of community-acquired pneumonia: a randomised superiority trial

Abstract number: 1134_02_82

Mouton Y., Thamlikitkul V., Nieman R.B., Janus C.

Objectives:

Macrolides and beta-lactams are commonly recommended for the treatment of outpatients with community-acquired pneumonia (CAP). The aim of this study was to demonstrate the superiority of the ketolide telithromycin (TEL) to other first-line, oral, single-agent antibiotics (comparators, COMP) in achieving clinical cure in outpatients with mild to moderate CAP in geographical areas of high pneumococcal resistance (erythromycin resistance rate >= 30%).

Methods:

Patients with clinical and radiological evidence of CAP were randomised centrally to receive either TEL 800 mg once daily for 7–10 days or COMP (chosen by the investigator in accordance with local treatment guidelines/practices). Efficacy was assessed post-therapy (Days 17–21). Clinical outcomes in this open-label trial were validated by three independent experts who were fully blinded to treatment assigned.

Results:

Of the 505 patients enrolled, 482 were included in the modified intent to treat (mITT) and 438 in the per protocol (PP) efficacy analyses. In the COMP group, 39% of patients had received macrolides, 44% beta-lactams and 17% fluoroquinolones. Resistance to penicillin and erythromycin among Streptococcus pneumoniae isolates was 28% and 31%, respectively. Clinical cure rates in the TEL group were significantly higher than those in the COMP group (as shown in the following table).

TEL and COMP were similarly well tolerated.

 Post-therapy clinical cure rates, % (n/N)
PopulationTELCOMPDifference [95% Cl]p-value
mITT (investigator's analysis)86.0% (208/242)78.8% (189/240)[0.004, 0.140]0.04
mITT (blinded experts' analysis)a92.1% (223/242)85.8% (206/240)[0.008, 0.119]0.03
PP (investigator's analysis)87.2% (191/219)79.9% (175/219)[0.004, 0.142]0.05
PP (blinded experts' analysis)a94.1% (206/219)87.7% (192/219)[0.010, 0.118]0.03
aClinical failure = subsequent antibiotic for lower respiratory tract infection or CAP-related fever post-therapy.

Conclusions:

In this outpatient CAP study, post-therapy clinical cure rates achieved with TEL were shown to be statistically superior to those achieved with other usual care first-line antibiotics – in both the mITT and PP populations, and according to evaluations by both the investigators and blinded experts.

Session Details

Date: 01/08/2007
Time: 00:00-00:00
Session name: XXIst ISTH Congress
Subject:
Location: Oxford, UK
Presentation type:
Back to top