Objectives: To compare the efficacy and safety of ertapenem, 1 g once a day, with ceftriaxone, 1 g once a day, for treatment of the subgroup of patients aged 65 and older with community-acquired pneumonia (CAP) requiring parenteral therapy.
Design: Combined data from patients aged 65 and older in two randomized, double-blind clinical trials.
Setting: Eighty international centers.
Participants: Eight hundred fifty-seven treated patients, of whom 351 were aged 65 and older.
Interventions: Intravenous or intramuscular ertapenem or ceftriaxone with the option to switch to oral amoxicillin-clavulanate after at least 3 days of parenteral therapy.
Measurements: Clinical efficacy was assessed at completion of parenteral therapy and 7 to 14 days after all therapy had been completed (test of cure (TOC) assessment). Bacterial eradication was assessed at the TOC visit. Safety was assessed daily during study therapy and for 14 days thereafter.
Results: One hundred forty-eight clinically evaluable patients aged 65 and older were treated with ertapenem and 125 with ceftriaxone. Pathogens were identified in 157 (57.5%) patients (the most common being Streptococcus pneumoniae), most of which were penicillin-susceptible. Clinical cure rates were 95.9% for patients in the ertapenem group and 92.7% for patients in the ceftriaxone group at completion of parenteral therapy and 93.9% and 90.4%, respectively, at the TOC assessment. Overall bacterial eradication rates were 92.8% (77 of 83) for patients treated with ertapenem and 93.2% (69 of 74) for those treated with ceftriaxone. The most common drug-related adverse experiences in both treatment groups were diarrhea and mild to moderate elevation of serum aminotransferase levels.
Conclusion: Ertapenem 1 g once a day was highly effective for treatment of elderly patients with CAP requiring parenteral therapy and was as effective as ceftriaxone. Ertapenem was generally well tolerated, with an overall safety profile similar to ceftriaxone.