title: [Efficacy of monotherapy by meropenem in ventilator-associated pneumonia].
abstract: We performed a prospective, open label, randomized study in intensive care unit patients with ventilator-associated pneumonia (VAP) to determine the efficacy and safety of empiric intravenous (i.v.) meropenem monotherapy compared with the combination of ceftazidime plus amikacin. A total of 140 patients receiving mechanical ventilation and diagnosed with pneumonia were included in the study. Patients were randomized to receive either 1 g meropenem i.v. every 8 hours or 2 g ceftazidime i.v. every 8 hours plus 15 mg/kg amikacin daily, administered to patients with normal renal function as two daily doses. Satisfactory clinical responses (cure or improvement) were achieved at the end of treatment in 68.1% of meropenem-treated patients and 54.9% in the ceftazidime/amikacin treated group (relative risk 1.25; 95% confidence interval > 1.00, 1.55). When non-evaluable patients were excluded from the analysis, the satisfactory clinical response was 82.5% and 66.1% for the meropenem and ceftazidime/amikacin patients, respectively (p = 0.044). Logistic regression demonstrated that treatment with meropenem and both the basic traumatic and medical pathologies were significantly associated with a satisfactory response. Adverse events judged to be possible or probably related to treatment were reported by seven (10.1%) patients in the meropenem group and by eight patients (11.3%) in the ceftazidime/amikacin group. The results of this study confirm that monotherapy with meropenem is well tolerated and provides superior efficacy to the conventional combination of ceftazidime and amikacin in combating VAP.
authors.affiliation: Servicio de Medicina Intensiva, Hospital del Mar, Paseo Maritimo 25-29, 08003 Barcelona, Spain. 16839@imas.imim.es
authors.forename: F
authors.initials: F
authors.lastname: Alvarez Lerma
mesh_terms: D000583:Amikacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002442:Ceftazidime / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003428:Cross Infection / Q000188:drug therapy / Q000382:microbiology / Q000401:mortality; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D000077731:Meropenem; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D011446:Prospective Studies; D012121:Respiration, Artificial / Q000009:adverse effects* / Q000295:instrumentation; D015163:Superinfection / Q000188:drug therapy / Q000209:etiology / Q000401:mortality; D013845:Thienamycins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D013845:Thienamycins; D000583:Amikacin; D002442:Ceftazidime; D000077731:Meropenem