Clinical and bacteriologic efficacy of telithromycin in patients with bacteremic community-acquired pneumonia.

This retrospective analysis was performed to determine the clinical and bacteriologic efficacy of the ketolide antibacterial telithromycin in patients with community-acquired pneumonia (CAP) with pneumococcal bacteremia. Patients 13 years old with radiologically confirmed CAP and a positive blood culture for Streptococcus pneumoniae at screening were analyzed from eight multicenter Phase III/IV clinical trials. In four open-label, non-comparative studies, patients received telithromycin 800 mg once daily for 7-10 days. In four randomized, controlled, double-blind, comparative studies, patients received telithromycin 800 mg once daily for 5-10 days or a comparator antimicrobial (amoxicillin 1000 mg three times daily, clarithromycin 500 mg twice daily, or trovafloxacin 200 mg once daily) for 7-10 days. In total, 118 patients (telithromycin, 94/1061 [8.9%]; comparator, 24/244 [9.8%]) had documented pneumococcal bacteremia. Those who were treated with telithromycin achieved a clinical cure rate of 90.2% (74/82, per-protocol population); S. pneumoniae was eradicated in 77/82 (93.9%) bacteremic patients who received telithromycin and 15/19 (78.9%) comparator-treated patients. Clinical cure was also observed among telithromycin-treated bacteremic patients who were infected with penicillin- or erythromycin-resistant strains of S. pneumoniae (5/7 and 8/10, respectively). In conclusion, telithromycin achieves high clinical and bacteriologic cure rates in CAP patients with pneumococcal bacteremia.

Bacteriological efficacy of 5-day therapy with telithromycin in acute maxillary sinusitis.

Increasing resistance among the key pathogens responsible for community-acquired respiratory tract infections, namely Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, has the potential to limit the effectiveness of the antibacterial agents available to treat these infections. Moreover, there are regional differences in the susceptibility patterns observed and, as treatment is usually empirical, choosing an effective treatment can be challenging. Telithromycin, the first ketolide to be approved for clinical use, offers an activity profile that covers the key respiratory pathogens including penicillin- and macrolide-resistant S. pneumoniae as well as beta-lactamase-producing H. influenzae and M. catarrhalis. In a pooled analysis of three large controlled clinical trials involving patients with acute maxillary sinusitis, the bacteriological efficacy of 5- or 10-day treatment with telithromycin and 10-day treatment with comparators was evaluated. Telithromycin administered as a once-daily 800 mg dose for 5 days achieved eradication rates of 91.8, 87.5 and 92.9% for S. pneumoniae, H. influenzae and M. catarrhalis, respectively. Bacteriological eradication of 8/10 and 12/14 isolates of S. pneumoniae resistant to penicillin and erythromycin, respectively, was also reported following 5-day treatment with telithromycin. The clinical efficacy of this regimen was equivalent to that of a 10-day regimen of telithromycin or standard 10-day courses of amoxicillin-clavulanic acid or cefuroxime axetil. Telithromycin 800mg given for 5 days was well tolerated, with the majority of adverse events being of mild or moderate intensity. These data suggest that telithromycin provides effective first-line therapy for use in patients with acute maxillary sinusitis in a short and convenient once-daily dosage regimen.

Clinical and bacteriological efficacy of 5-day telithromycin in acute maxillary sinusitis: a pooled analysis.

OBJECTIVES: To compare the efficacy and tolerability of a 5-day course of telithromycin (800 mg once daily) with a 10-day course of telithromycin or standard comparators (amoxicillin-clavulanate 500/125 mg three times daily or cefuroxime axetil 250 mg twice daily) in patients with acute maxillary sinusitis (AMS). METHODS: Data from three randomised double blind studies were pooled. The studies included patients with clinical symptoms of AMS and sinus X-ray findings of total opacity, air-fluid levels or mucosal thickening. RESULTS: Pooled analysis of results for 5-day telithromycin revealed overall clinical cure rates of 83.6% (383/458 patients) at post-therapy (days 17-24) and 78.9% (330/418 patients) at late post-therapy (days 31-45) in the per-protocol population. Clinical cure rates at post-therapy were equivalent to those observed with 10-day telithromycin (82.5% vs 81.7%) or comparator treatment (80.9% vs 77.4%). Moreover, clinical cure rates exceeded 80% in subgroups of patients of interest, including those with severe infection and those fulfilling more stringent criteria for bacterial AMS. A satisfactory bacteriological outcome was achieved in 87.6% of patients. The 5-day telithromycin regimen was well tolerated. CONCLUSIONS: Telithromycin once daily for 5 days offers effective treatment for AMS and is comparable to 10-day courses of standard treatments.

Telithromycin for the treatment of acute exacerbations of chronic bronchitis.

Pooled data from three randomized, double-blind, multi- centre studies evaluated the efficacy and tolerability of telithromycin 800 mg once daily for 5 days vs. standard comparators (10-day amoxicillin-clavulanate 500/125 mg three times daily, clarithromycin 500 mg or cefuroxime axetil 500 mg twice daily) in the outpatient treatment for acute exacerbations of chronic bronchitis. Per-protocol clinical cure rates at post-therapy/test of cure (days 17-24) were 86.0 and 85.8% for telithromycin and comparators, respectively, and 79.1 and 78.7%, respectively, at late post-therapy (days 31-36). Clinical cure rates were comparable for patients at increased risk, including those of > or =65 years and those with severe infection or significant airway obstruction (telithromycin, > or =77.1%; comparators, > or =75.0%). Telithromycin was well tolerated. Most adverse events considered possibly related to study medication were gastrointestinal and of mild intensity. In conclusion, 5-day telithromycin therapy is as effective and well tolerated as 10-day treatment with standard comparators.

Predicting influenza infections during epidemics with use of a clinical case definition.

Combined pharyngeal and nasal swab specimens were collected from 100 subjects who presented with a flu-like illness (fever >37.8 degrees C plus 2 of 4 symptoms: cough, myalgia, sore throat, and headache) of <72 hours' duration at 3 different clinics in the province of Quebec, Canada, during the 1998-1999 flu season. The rate of laboratory-confirmed influenza infection was 72% according to cell culture findings and 79% according to the results of multiplex reverse-transcription polymerase chain reaction (RT-PCR) analysis (85%, influenza AH3; 15%, influenza B). All subjects for whom these results were discordant (negative culture and positive PCR) presented with a temperature > or =38.2 degrees C as well as 3 or 4 of the symptoms in the clinical case definition. Stepwise logistic regression showed that cough (odds ratio [OR], 6.7; 95% confidence interval [CI], 1.4-34.1; P=.02) and fever (OR, 3.1; 95% CI, 1.4-8.0; P=.01) were the only factors significantly associated with a positive PCR test for influenza. The positive predictive value, negative predictive value, sensitivity, and the specificity of a case definition including fever (temperature of >38 degrees C) and cough for the diagnosis of influenza infection during this flu season were 86.8%, 39.3%, 77.6%, and 55.0%, respectively.