EMPIRIC TREATMENT OF HOSPITAL-ACQUIRED LOWER RESPIRATORY-TRACT INFECTIONS WITH MEROPENEM OR CEFTAZIDIME WITH TOBRAMYCIN - A RANDOMIZED STUDY

Objective: To evaluate the efficacy and tolerability of intravenous em piric treatment with meropenem compared with ceftazidime-tobramycin in patients with hospital-acquired lower respiratory tract infections. D esign: Prospective, nonblind, randomized trial. Setting: Multicenter t rial conducted at 22 centers. Patients: Two hundred eleven patients we re enrolled and 121 were evaluable for the analysis of both clinical a nd bacteriologic efficacy. Interventions: One hundred four patients we re randomized to receive intravenous meropenem (1000 mg) every 8 hrs a nd 107 patients were randomized to receive intravenous ceftazidime (20 00 mg) plus tobramycin (1 mg/kg) every 8 hrs, Sixty-three mere penem-t reated patients and 58 ceftazidime-tobramycin-treated patients were el igible for the analysis of clinical and bacteriologic efficacy. In the ceftazidime tobramycin group, 32 (55%) evaluable patients received mo re than six doses of tobramycin, 24 (41%) received six doses or fewer, and two (3%) did not receive any tobramycin. Measurements and Main Re sults: The analysis of efficacy was based on the clinical and bacterio logic responses at the end of treatment, Satisfactory clinical respons es occurred in 56 (89%) of 63 of the meropenem-treated patients and in 42 (72%) of 58 of the ceftazidime-tobramycin treated patients (p = .0 4), Corresponding bacteriologic response rates were 89% and 67%, respe ctively (p = .006). The frequency and profile of drug-related adverse events was similar across treatment groups, Seizures were reported in three meropenem-treated patients, but these seizures were considered b y the investigator to be unrelated to treatment. Conclusions: Meropene m is well tolerated and more efficacious than the combination of cefta zidime and tobramycin for the initial empiric treatment of hospital-ac quired bacterial pneumonia.